Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-04-15 @ 6:09 AM
Study NCT ID:
NCT00852995
Status:
COMPLETED
Last Update Posted:
2016-10-24
First Post:
2009-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Finding Study of HP802-247 in Venous Leg Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jaime.Dickerson@smith-nephew.com', 'phone': '1-817-302-3914', 'title': 'Jamie E Dickerson, PhD', 'organization': 'Smith & Nephew'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The duration of the 12-week treatment period', 'description': 'All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution', 'otherNumAtRisk': 50, 'otherNumAffected': 26, 'seriousNumAtRisk': 50, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.', 'otherNumAtRisk': 46, 'otherNumAffected': 15, 'seriousNumAtRisk': 46, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.', 'otherNumAtRisk': 43, 'otherNumAffected': 19, 'seriousNumAtRisk': 43, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.', 'otherNumAtRisk': 44, 'otherNumAffected': 16, 'seriousNumAtRisk': 43, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.', 'otherNumAtRisk': 45, 'otherNumAffected': 17, 'seriousNumAtRisk': 45, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Skin and subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 26, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 17, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}], 'seriousEvents': [{'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Excessive granulation tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 12.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG001', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG002', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG003', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG004', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-77.11', 'spread': '21.95', 'groupId': 'OG000'}, {'value': '-70.15', 'spread': '21.66', 'groupId': 'OG001'}, {'value': '-68.14', 'spread': '26.29', 'groupId': 'OG002'}, {'value': '-72.89', 'spread': '27.27', 'groupId': 'OG003'}, {'value': '-60.38', 'spread': '29.79', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.00028', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0899', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1586', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0295', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first', 'description': "For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P \\< 0.05.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Probability of Non-Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}, {'id': 'OG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}], 'classes': [{'title': '01 week', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0.977', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '02 weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0.978', 'groupId': 'OG001'}, {'value': '0.977', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0.978', 'groupId': 'OG004'}]}]}, {'title': '03 weeks', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000'}, {'value': '0.934', 'groupId': 'OG001'}, {'value': '0.977', 'groupId': 'OG002'}, {'value': '0.953', 'groupId': 'OG003'}, {'value': '0.889', 'groupId': 'OG004'}]}]}, {'title': '04 weeks', 'categories': [{'measurements': [{'value': '0.918', 'groupId': 'OG000'}, {'value': '0.934', 'groupId': 'OG001'}, {'value': '0.907', 'groupId': 'OG002'}, {'value': '0.907', 'groupId': 'OG003'}, {'value': '0.867', 'groupId': 'OG004'}]}]}, {'title': '05 weeks', 'categories': [{'measurements': [{'value': '0.898', 'groupId': 'OG000'}, {'value': '0.71', 'groupId': 'OG001'}, {'value': '0.814', 'groupId': 'OG002'}, {'value': '0.791', 'groupId': 'OG003'}, {'value': '0.707', 'groupId': 'OG004'}]}]}, {'title': '06 weeks', 'categories': [{'measurements': [{'value': '0.834', 'groupId': 'OG000'}, {'value': '0.596', 'groupId': 'OG001'}, {'value': '0.814', 'groupId': 'OG002'}, {'value': '0.791', 'groupId': 'OG003'}, {'value': '0.661', 'groupId': 'OG004'}]}]}, {'title': '07 weeks', 'categories': [{'measurements': [{'value': '0.706', 'groupId': 'OG000'}, {'value': '0.596', 'groupId': 'OG001'}, {'value': '0.628', 'groupId': 'OG002'}, {'value': '0.741', 'groupId': 'OG003'}, {'value': '0.591', 'groupId': 'OG004'}]}]}, {'title': '08 weeks', 'categories': [{'measurements': [{'value': '0.663', 'groupId': 'OG000'}, {'value': '0.431', 'groupId': 'OG001'}, {'value': '0.581', 'groupId': 'OG002'}, {'value': '0.537', 'groupId': 'OG003'}, {'value': '0.543', 'groupId': 'OG004'}]}]}, {'title': '09 weeks', 'categories': [{'measurements': [{'value': '0.534', 'groupId': 'OG000'}, {'value': '0.359', 'groupId': 'OG001'}, {'value': '0.558', 'groupId': 'OG002'}, {'value': '0.537', 'groupId': 'OG003'}, {'value': '0.445', 'groupId': 'OG004'}]}]}, {'title': '10 weeks', 'categories': [{'measurements': [{'value': '0.512', 'groupId': 'OG000'}, {'value': '0.332', 'groupId': 'OG001'}, {'value': '0.558', 'groupId': 'OG002'}, {'value': '0.537', 'groupId': 'OG003'}, {'value': '0.418', 'groupId': 'OG004'}]}]}, {'title': '11 weeks', 'categories': [{'measurements': [{'value': '0.512', 'groupId': 'OG000'}, {'value': '0.332', 'groupId': 'OG001'}, {'value': '0.393', 'groupId': 'OG002'}, {'value': '0.46', 'groupId': 'OG003'}, {'value': '0.418', 'groupId': 'OG004'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.512', 'groupId': 'OG000'}, {'value': '0.276', 'groupId': 'OG001'}, {'value': '0.393', 'groupId': 'OG002'}, {'value': '0.379', 'groupId': 'OG003'}, {'value': '0.288', 'groupId': 'OG004'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000'}, {'value': '0.237', 'groupId': 'OG001'}, {'value': '0.393', 'groupId': 'OG002'}, {'value': '0.32', 'groupId': 'OG003'}, {'value': '0.288', 'groupId': 'OG004'}]}]}, {'title': '14 weeks', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.393', 'groupId': 'OG002'}, {'value': '0.32', 'groupId': 'OG003'}, {'value': '0.288', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 weeks - the final visit for one subject was delayed by two weeks', 'description': 'This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.', 'unitOfMeasure': 'Probability of Non-Closure', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P \\< 0.05.'}, {'type': 'SECONDARY', 'title': 'Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}, {'id': 'OG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}], 'classes': [{'title': 'Tx Week 1', 'categories': [{'measurements': [{'value': '-22.94', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '-38.88', 'spread': '4.14', 'groupId': 'OG001'}, {'value': '-27.89', 'spread': '4.27', 'groupId': 'OG002'}, {'value': '-25.88', 'spread': '4.26', 'groupId': 'OG003'}, {'value': '-34.97', 'spread': '4.17', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 2', 'categories': [{'measurements': [{'value': '-39.94', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-58.95', 'spread': '5.11', 'groupId': 'OG001'}, {'value': '-46.06', 'spread': '5.26', 'groupId': 'OG002'}, {'value': '-43.69', 'spread': '5.26', 'groupId': 'OG003'}, {'value': '-49.89', 'spread': '5.14', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 3', 'categories': [{'measurements': [{'value': '-47.30', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-65.56', 'spread': '5.22', 'groupId': 'OG001'}, {'value': '-53.5', 'spread': '5.37', 'groupId': 'OG002'}, {'value': '-55.2', 'spread': '5.37', 'groupId': 'OG003'}, {'value': '-56.66', 'spread': '5.25', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 4', 'categories': [{'measurements': [{'value': '-59.55', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '-73.46', 'spread': '5.51', 'groupId': 'OG001'}, {'value': '-62.14', 'spread': '5.68', 'groupId': 'OG002'}, {'value': '-60.68', 'spread': '5.68', 'groupId': 'OG003'}, {'value': '-63.92', 'spread': '5.55', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 5', 'categories': [{'measurements': [{'value': '-60.54', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '-79.98', 'spread': '5.52', 'groupId': 'OG001'}, {'value': '-68.95', 'spread': '5.68', 'groupId': 'OG002'}, {'value': '-61.87', 'spread': '5.68', 'groupId': 'OG003'}, {'value': '-72.41', 'spread': '5.55', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 6', 'categories': [{'measurements': [{'value': '-63.93', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '-81.05', 'spread': '4.83', 'groupId': 'OG001'}, {'value': '-76.01', 'spread': '4.98', 'groupId': 'OG002'}, {'value': '-74.7', 'spread': '4.97', 'groupId': 'OG003'}, {'value': '-81.06', 'spread': '4.86', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 7', 'categories': [{'measurements': [{'value': '-65.38', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '-87.22', 'spread': '4.84', 'groupId': 'OG001'}, {'value': '-79.84', 'spread': '4.99', 'groupId': 'OG002'}, {'value': '-77.63', 'spread': '4.98', 'groupId': 'OG003'}, {'value': '-79.81', 'spread': '4.87', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 8', 'categories': [{'measurements': [{'value': '-66.62', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '-83.00', 'spread': '5.26', 'groupId': 'OG001'}, {'value': '-80.6', 'spread': '5.42', 'groupId': 'OG002'}, {'value': '-81.58', 'spread': '5.42', 'groupId': 'OG003'}, {'value': '-81.98', 'spread': '5.3', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 9', 'categories': [{'measurements': [{'value': '-69.03', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '-83.28', 'spread': '4.99', 'groupId': 'OG001'}, {'value': '-83.96', 'spread': '5.14', 'groupId': 'OG002'}, {'value': '-84.28', 'spread': '5.14', 'groupId': 'OG003'}, {'value': '-86.17', 'spread': '5.02', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 10', 'categories': [{'measurements': [{'value': '-76.19', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '-89.65', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '-85.79', 'spread': '3.65', 'groupId': 'OG002'}, {'value': '-86.98', 'spread': '3.65', 'groupId': 'OG003'}, {'value': '-87.74', 'spread': '3.56', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 11', 'categories': [{'measurements': [{'value': '-77.05', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '-89.26', 'spread': '3.72', 'groupId': 'OG001'}, {'value': '-87.49', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '-83.37', 'spread': '3.83', 'groupId': 'OG003'}, {'value': '-87.54', 'spread': '3.75', 'groupId': 'OG004'}]}]}, {'title': 'Tx Week 12', 'categories': [{'measurements': [{'value': '-80.69', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '-90.67', 'spread': '3.69', 'groupId': 'OG001'}, {'value': '-86.87', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '-84.52', 'spread': '3.8', 'groupId': 'OG003'}, {'value': '-86.93', 'spread': '3.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.037', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 01', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.064', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 02', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.161', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 03', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.39', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.079', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.069', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 06', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.026', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 07', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.133', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.089', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 09', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.057', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.127', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.395', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Treatment Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first', 'description': "For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P \\< 0.05.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}, {'id': 'OG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}], 'classes': [{'title': 'Visit 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Visit 3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': 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'testedNonInferiority': False}, {'pValue': '0.8435', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 04', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8743', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 04', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2884', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 04', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0387', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8461', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9574', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2994', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1024', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 06', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8759', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 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False}, {'pValue': '0.208', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 08', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0413', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 08', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 09', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2031', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 09', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0894', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 09', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0288', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 09', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6964', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7146', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5008', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1235', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5488', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4343', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1114', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2119', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0194', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.506', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2317', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1144', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 13', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6786', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 13', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7735', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 13', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.758', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Visit 13', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Over the 12 week treatment period or until the wound closed, which ever occurred first.', 'description': "The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.", 'unitOfMeasure': 'Responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Wound Closure at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}, {'id': 'OG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}], 'classes': [{'title': 'Week 01', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '2.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 02', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}, {'value': '2.3', 'groupId': 'OG002'}, {'value': '7.0', 'groupId': 'OG003'}, {'value': '11.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 03', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '23.9', 'groupId': 'OG001'}, {'value': '9.3', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 04', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '18.6', 'groupId': 'OG002'}, {'value': '20.9', 'groupId': 'OG003'}, {'value': '28.9', 'groupId': 'OG004'}]}]}, {'title': 'Week 05', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}, {'value': '25.6', 'groupId': 'OG002'}, {'value': '23.3', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 06', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}, {'value': '39.5', 'groupId': 'OG002'}, {'value': '27.9', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 07', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '52.2', 'groupId': 'OG001'}, {'value': '41.9', 'groupId': 'OG002'}, {'value': '39.5', 'groupId': 'OG003'}, {'value': '44.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 08', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '58.7', 'groupId': 'OG001'}, {'value': '41.9', 'groupId': 'OG002'}, {'value': '48.8', 'groupId': 'OG003'}, {'value': '51.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 09', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}, {'value': '55.8', 'groupId': 'OG002'}, {'value': '48.8', 'groupId': 'OG003'}, {'value': '55.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}, {'value': '60.5', 'groupId': 'OG002'}, {'value': '53.5', 'groupId': 'OG003'}, {'value': '62.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '65.2', 'groupId': 'OG001'}, {'value': '58.1', 'groupId': 'OG002'}, {'value': '60.5', 'groupId': 'OG003'}, {'value': '64.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}, {'value': '58.1', 'groupId': 'OG002'}, {'value': '65.1', 'groupId': 'OG003'}, {'value': '64.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 04', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.041', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 04', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.017', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.011', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 06', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.014', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 07', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.029', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 08', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.021', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 09', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.041', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.044', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.013', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.024', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.027', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly, over the 12 week treatment period', 'description': 'Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test'}, {'type': 'SECONDARY', 'title': 'Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}, {'id': 'OG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '30.82', 'spread': '31.22', 'groupId': 'OG000'}, {'value': '21.11', 'spread': '25.23', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '21.77', 'groupId': 'OG002'}, {'value': '29.84', 'spread': '26.36', 'groupId': 'OG003'}, {'value': '25.47', 'spread': '27.7', 'groupId': 'OG004'}]}]}, {'title': 'Week 03', 'categories': [{'measurements': [{'value': '21.68', 'spread': '25.01', 'groupId': 'OG000'}, {'value': '13.37', 'spread': '18.61', 'groupId': 'OG001'}, {'value': '16.87', 'spread': '19.22', 'groupId': 'OG002'}, {'value': '18.81', 'spread': '22.15', 'groupId': 'OG003'}, {'value': '14.42', 'spread': '18.17', 'groupId': 'OG004'}]}]}, {'title': 'Week 06', 'categories': [{'measurements': [{'value': '10.72', 'spread': '18.22', 'groupId': 'OG000'}, {'value': '10.35', 'spread': '20.43', 'groupId': 'OG001'}, {'value': '7.35', 'spread': '13.36', 'groupId': 'OG002'}, {'value': '12.25', 'spread': '17.96', 'groupId': 'OG003'}, {'value': '11.61', 'spread': '19.03', 'groupId': 'OG004'}]}]}, {'title': 'Week 09', 'categories': [{'measurements': [{'value': '9.3', 'spread': '14.96', 'groupId': 'OG000'}, {'value': '8.85', 'spread': '18.53', 'groupId': 'OG001'}, {'value': '4.53', 'spread': '9.54', 'groupId': 'OG002'}, {'value': '11.51', 'spread': '18.29', 'groupId': 'OG003'}, {'value': '7.01', 'spread': '13.63', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '7.95', 'spread': '13.34', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '11.72', 'groupId': 'OG001'}, {'value': '3.28', 'spread': '6.83', 'groupId': 'OG002'}, {'value': '13.22', 'spread': '20.71', 'groupId': 'OG003'}, {'value': '6.61', 'spread': '13.43', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, over the 12 week treatment period', 'description': 'Target ulcer pain was measured using a Visual Analog Scale \\[Range: 0mm - 100mm\\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.'}, {'type': 'SECONDARY', 'title': 'Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}, {'id': 'OG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'OG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'comment': 'Unable to assess upper limit. The placebo did not reach 50% closure.', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': 'NA'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '66'}, {'value': '64', 'comment': 'Unable to assess upper limit. The placebo did not reach 50% closure.', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': 'NA'}, {'value': '57', 'groupId': 'OG003', 'lowerLimit': '50', 'upperLimit': '85'}, {'value': '57', 'groupId': 'OG004', 'lowerLimit': '43', 'upperLimit': '71'}]}]}], 'analyses': [{'pValue': '0.0211', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for Kaplan-Meier Days to Closure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.0212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '1.09', 'ciUpperLimit': '3.04', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.53', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '.69', 'ciUpperLimit': '2.05', 'pValueComment': 'This is the P-value for the Cox Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.26', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kaplan-Meier Days to Closure', 'testedNonInferiority': False}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.44', 'pValueComment': 'This is the P-value for the Cox Proportional Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for Kaplan Meier Days to Closure', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '0.97', 'ciUpperLimit': '2.77', 'pValueComment': 'P-value for Cox Proportional Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '14 weeks - the final visit for one subject was delayed by two weeks', 'description': 'This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.', 'unitOfMeasure': 'Days to Closure', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P \\< 0.05.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'FG001', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'FG002', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'FG003', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'FG004', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Moved Out of Area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were screened at 34 sites in the US and one in Canada, between June 11, 2009 and May 5, 2011; sites included independent and hospital wound clinics and private practice sites.', 'preAssignmentDetails': 'Subjects entered a 2-week run-in; subjects whose wound radius decreased by \\< 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '228', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'E - HP802-247 Vehicle', 'description': 'Placebo (Vehicle), applied at each visit\n\nPlacebo (Vehicle): Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution'}, {'id': 'BG001', 'title': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'BG002', 'title': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'BG003', 'title': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'BG004', 'title': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit\n\nHP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '61.7', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '15.4', 'groupId': 'BG002'}, {'value': '59.8', 'spread': '15.0', 'groupId': 'BG003'}, {'value': '61.8', 'spread': '16.1', 'groupId': 'BG004'}, {'value': '61.6', 'spread': '15.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Female Age', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '90'}, {'value': '61.8', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '87'}, {'value': '67.7', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '89'}, {'value': '65.1', 'groupId': 'BG003', 'lowerLimit': '27', 'upperLimit': '89'}, {'value': '69.7', 'groupId': 'BG004', 'lowerLimit': '39', 'upperLimit': '94'}, {'value': '66.5', 'groupId': 'BG005', 'lowerLimit': '24', 'upperLimit': '94'}]}]}, {'title': 'Male Age', 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '91'}, {'value': '61.6', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '88'}, {'value': '60.1', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '93'}, {'value': '56.0', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '75'}, {'value': '58.2', 'groupId': 'BG004', 'lowerLimit': '24', 'upperLimit': '80'}, {'value': '59.0', 'groupId': 'BG005', 'lowerLimit': '22', 'upperLimit': '93'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '135', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '173', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '164', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'dispFirstSubmitDate': '2013-09-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2009-02-26', 'dispFirstSubmitQcDate': '2013-09-19', 'resultsFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2009-02-26', 'dispFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-15', 'studyFirstPostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.', 'timeFrame': 'Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first', 'description': "For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed."}], 'secondaryOutcomes': [{'measure': 'Kaplan-Meier Probability of Non-Closure', 'timeFrame': '14 weeks - the final visit for one subject was delayed by two weeks', 'description': 'This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.'}, {'measure': 'Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.', 'timeFrame': 'Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first', 'description': "For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area."}, {'measure': 'Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13', 'timeFrame': 'Over the 12 week treatment period or until the wound closed, which ever occurred first.', 'description': "The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group."}, {'measure': 'Percentage of Participants With Complete Wound Closure at Each Visit', 'timeFrame': 'Weekly, over the 12 week treatment period', 'description': 'Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.'}, {'measure': 'Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.', 'timeFrame': 'Weekly, over the 12 week treatment period', 'description': 'Target ulcer pain was measured using a Visual Analog Scale \\[Range: 0mm - 100mm\\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.'}, {'measure': 'Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.', 'timeFrame': '14 weeks - the final visit for one subject was delayed by two weeks', 'description': 'This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Venous Leg Ulcer (VLU)', 'Venous Stasis Ulcer (VSU)', 'VLU', 'VSU', 'Leg Ulcer', 'Leg Wound'], 'conditions': ['Venous Leg Ulcer', 'Venous Stasis Ulcers']}, 'referencesModule': {'references': [{'pmid': '22863328', 'type': 'DERIVED', 'citation': 'Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2012 Sep 15;380(9846):977-85. doi: 10.1016/S0140-6736(12)60644-8. Epub 2012 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide informed consent.\n* Willing to comply with protocol instructions, including allowing all study assessments.\n* Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.\n* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.\n* Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.\n* A target ulcer of non-venous etiologies.\n* Refusal of or inability to tolerate compression therapy.\n* Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.\n* Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.'}, 'identificationModule': {'nctId': 'NCT00852995', 'briefTitle': 'Dose Finding Study of HP802-247 in Venous Leg Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthpoint'}, 'officialTitle': 'A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers', 'orgStudyIdInfo': {'id': '802-247-09-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - Low Q7D', 'description': 'Low dose HP802-247, applied at each visit', 'interventionNames': ['Biological: HP802-247']}, {'type': 'EXPERIMENTAL', 'label': 'B - Low Q14D', 'description': 'Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12', 'interventionNames': ['Biological: HP802-247']}, {'type': 'EXPERIMENTAL', 'label': 'C - High Q7D', 'description': 'High dose HP802-247, applied at each visit', 'interventionNames': ['Biological: HP802-247']}, {'type': 'EXPERIMENTAL', 'label': 'D - High Q14D', 'description': 'High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12', 'interventionNames': ['Biological: HP802-247']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E - Vehicle', 'description': 'Placebo (Vehicle), applied at each visit', 'interventionNames': ['Biological: Placebo (Vehicle)']}], 'interventions': [{'name': 'HP802-247', 'type': 'BIOLOGICAL', 'description': 'One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.', 'armGroupLabels': ['A - Low Q7D', 'B - Low Q14D', 'C - High Q7D', 'D - High Q14D']}, {'name': 'Placebo (Vehicle)', 'type': 'BIOLOGICAL', 'description': 'Placebo (Vehicle) consisting of:\n\nComponent 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution', 'armGroupLabels': ['E - Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of AZ College of Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clinical Research', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'ILD Consulting, Inc.', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Vascular Surgery Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92013', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Wound Treatment and Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Doctors Research Network', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Robert J. Snyder', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '60154', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62650', 'city': 'Jacksonville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Passavant Area Hospital', 'geoPoint': {'lat': 39.73394, 'lon': -90.22901}}, {'zip': '60064', 'city': 'North Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rosalind Franklin University', 'geoPoint': {'lat': 42.32558, 'lon': -87.84118}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Wound Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02972', 'city': 'Stoughton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Sinai Hospital', 'geoPoint': {'lat': 42.1251, 'lon': -71.10227}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Advanced Foot and Ankle Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07630', 'city': 'Emerson', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Vincent Giacalone', 'geoPoint': {'lat': 40.97621, 'lon': -74.02625}}, {'zip': '10025', 'city': 'New York', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Luke's Roosevelt Hospital Center"}, {'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Overlook Hospital Wound Healing Program', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '17112', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Harrisburg Foot and Ankle Center', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19601', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for Advanced Wound Care', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Research Center', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '75093', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Wound Care Consultants', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Regional Wound Care Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Peripheral Vascular Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84770', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': "Dixie Regional Medical Center's Wound Clinic", 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Lake Washington Vascular, LLC', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart Medical Center Wound Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'N6C5J1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Aging Rehabilitation & Geriatric Care Research Center', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Herbert B Slade, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Healthpoint'}, {'name': 'William Marston, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'Robert Kirsner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Robert J Snyder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert J Snyder'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}