Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT00215735
Status:
TERMINATED
Last Update Posted:
2012-03-20
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Platelet Concentrate in Treatment of Diabetic Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003646', 'term': 'Debridement'}, {'id': 'D001458', 'term': 'Bandages'}, {'id': 'D057908', 'term': 'Argon Plasma Coagulation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D006488', 'term': 'Hemostasis, Surgical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'whyStopped': 'inconclusive results, market feasiblity', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-16', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['diabetes', 'Ulcer', 'APC'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds', 'detailedDescription': 'The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:chronic diabetic ulcer -\n\nExclusion Criteria:steroids, dialysis, vascular disease\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00215735', 'briefTitle': 'Effect of Platelet Concentrate in Treatment of Diabetic Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Harvest Technologies'}, 'officialTitle': 'Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers', 'orgStudyIdInfo': {'id': '2003-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APC Treatment', 'description': 'wound debridement and treatment with APC', 'interventionNames': ['Device: debridement, dressing, and APC']}], 'interventions': [{'name': 'debridement, dressing, and APC', 'type': 'DEVICE', 'description': 'ebridement, dressing, and APC', 'armGroupLabels': ['APC Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Alaska', 'country': 'United States', 'facility': 'Washington Regional Medical Center'}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Lucerne Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33708', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Pines V.A. Medical Center', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Medical Center Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Traveling Medical Services', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Blair Medical Associates', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '02908', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Roger Williams Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37115', 'city': 'Madison', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Christian Hospital', 'geoPoint': {'lat': 36.25616, 'lon': -86.71389}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Luke's Medical Ctr", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Mark Iafrati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Ctr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvest Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}