Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06403605
Status:
COMPLETED
Last Update Posted:
2025-11-07
First Post:
2024-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dbuck@etswoundcare.com', 'phone': '410-490-5998', 'title': 'Donald Buck, MD', 'organization': 'ETS Wound Care, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From enrollment until end of follow-up (up to 12 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 5, 'seriousNumAtRisk': 67, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.", 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 5, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Index wound infection', 'notes': 'Not including cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cystitis', 'notes': 'Not related to receiving the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep space infection of left plantar mid foot', 'notes': 'Not related to receiving the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis of sacrum', 'notes': 'Not related to receiving the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative infection of non-study wound', 'notes': 'Not related to receiving the intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotizing fasciitis', 'notes': 'Not related to receiving the intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-study diabetic foot wound infection with osteomyelitis', 'notes': 'Not related to receiving the intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death (due to underlying comorbidities)', 'notes': 'Not related to receiving the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septicemia (gram negative, from right foot abscess/cellulitis)', 'notes': 'Not related to receiving the intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'notes': 'Not related to receiving the intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute toxic encephalopathy', 'notes': 'Not related to receiving the intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis, right leg', 'notes': 'Not related to receiving the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anasarca', 'notes': 'Not related to receiving the intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral pleural effusions', 'notes': 'Not related to receiving the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'notes': 'Not related to receiving the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Percentage Area Reduction (PAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.'}, {'id': 'OG001', 'title': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing."}], 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.8', 'spread': '82.81', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '65.78', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '15.28', 'groupId': 'OG000'}, {'value': '89.7', 'spread': '25.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted p value in the mITT analysis population.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted p value in the PP analysis population.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.'}, {'type': 'SECONDARY', 'title': 'Time to Heal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.'}, {'id': 'OG001', 'title': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing."}], 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '70.1'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '67.3', 'upperLimit': '77.7'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '65.7'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '75.2'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted p-value in the mITT population.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.084', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted p value in the PP population.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The time to achieve complete wound closure within 12 weeks.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.'}, {'id': 'OG001', 'title': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing."}], 'classes': [{'title': 'Assessment (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.3', 'spread': '20.68', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '21.36', 'groupId': 'OG001'}]}]}, {'title': 'Drainage (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '22.77', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '20.83', 'groupId': 'OG001'}]}]}, {'title': 'Smell (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '23.06', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '18.42', 'groupId': 'OG001'}]}]}, {'title': 'Social (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '28.14', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '26.27', 'groupId': 'OG001'}]}]}, {'title': 'Dressing (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '18.04', 'groupId': 'OG001'}]}]}, {'title': 'Assessment (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '17.89', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '21.34', 'groupId': 'OG001'}]}]}, {'title': 'Drainage (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'spread': '19.58', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '18.57', 'groupId': 'OG001'}]}]}, {'title': 'Smell (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '20.73', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '17.59', 'groupId': 'OG001'}]}]}, {'title': 'Social (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '29.39', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '25.53', 'groupId': 'OG001'}]}]}, {'title': 'Dressing (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.2', 'spread': '20.85', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '18.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.'}, {'type': 'SECONDARY', 'title': 'Change in Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.'}, {'id': 'OG001', 'title': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing."}], 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain.', 'unitOfMeasure': 'score change [EOS - baseline]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.'}, {'type': 'PRIMARY', 'title': 'Complete Wound Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.'}, {'id': 'OG001', 'title': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing."}], 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'The proportion of subjects achieving complete wound closure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.'}, {'id': 'FG001', 'title': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing."}], 'periods': [{'title': 'Randomization and Initial Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Withdrawn per protocol with PAR <50% at week 6', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '245 subjects were assessed for eligibility to participate in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SOC Primary Dressing With MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.'}, {'id': 'BG001', 'title': 'SOC Primary Dressing With FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.1', 'spread': '16.81', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '14.26', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '15.50', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.2', 'spread': '16.34', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '15.60', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '15.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'BMI', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '8.45', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '8.98', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '8.71', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.3', 'spread': '9.06', 'groupId': 'BG000'}, {'value': '36.4', 'spread': '9.99', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '9.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Tobacco use', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Current', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Never used tobacco', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Current', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Never used tobacco', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Diabetes duration', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '13.59', 'groupId': 'BG000'}, {'value': '15.9', 'spread': '9.58', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '11.71', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '9.75', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '14.18', 'groupId': 'BG001'}, {'value': '16.0', 'spread': '11.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Age when first DFU appeared', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.2', 'spread': '11.56', 'groupId': 'BG000'}, {'value': '53.6', 'spread': '11.60', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '11.76', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.9', 'spread': '11.86', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '11.09', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '11.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Number of prior DFUs', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '4.27', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '4.96', 'groupId': 'BG001'}, {'value': '3.8', 'spread': '4.66', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.95', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '3.77', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '3.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'DFUs', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Number of other concurrent DFUs at screening', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '3 or more', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '3 or more', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'History of DFU recurrence', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Major amputation', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Minor amputations', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '3 or more', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '3 or more', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Major foot deformities', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Charcot', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Hammertoe', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Varus ankle', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Hallux valgis', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Cavus foot', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'None of the above', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Charcot', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Hammertoe', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Varus ankle', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Hallux valgis', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Cavus foot', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'None of the above', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Creatinine', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.42', 'groupId': 'BG000'}, {'value': '1.24', 'spread': '0.54', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '0.49', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.46', 'groupId': 'BG000'}, {'value': '1.19', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '1.1', 'spread': '0.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'HbA1c', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.69', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '1.65', 'groupId': 'BG001'}, {'value': '7.6', 'spread': '1.67', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.61', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '1.57', 'groupId': 'BG001'}, {'value': '7.6', 'spread': '1.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Wound area', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.81', 'groupId': 'BG000'}, {'value': '3.3', 'spread': '2.57', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '2.69', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.37', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '2.43', 'groupId': 'BG001'}, {'value': '2.9', 'spread': '2.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Wound age', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '13.26', 'groupId': 'BG000'}, {'value': '20.9', 'spread': '14.82', 'groupId': 'BG001'}, {'value': '20.9', 'spread': '14.00', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19.4', 'spread': '12.99', 'groupId': 'BG000'}, {'value': '21.3', 'spread': '14.55', 'groupId': 'BG001'}, {'value': '20.3', 'spread': '13.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Number of participants with index wound in each vertical location', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Plantar', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Dorsal', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Plantar', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Dorsal', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Index ulcer location is defined by the ulcer being on the left or right foot, by the vertical location of the ulcer on the foot (dorsal or plantar), anatomical location (toe, forefoot, midfoot, hind foot, ankle, or heel), and the positioning of the ulcer as lateral or medial located.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Number of participants with index wound in each position', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Medial', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Lateral', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Medial', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Lateral', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Index ulcer location is defined by the ulcer being on the left or right foot, by the vertical location of the ulcer on the foot (dorsal or plantar), anatomical location (toe, forefoot, midfoot, hind foot, ankle, or heel), and the positioning of the ulcer as lateral or medial located.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Number of participants with index wound in each anatomical location', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Toe', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Forefoot', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Midfoot', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Hindfoot', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Heel', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Ankle', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Toe', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Forefoot', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Midfoot', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Hindfoot', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Heel', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Ankle', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Index ulcer location is defined by the ulcer being on the left or right foot, by the vertical location of the ulcer on the foot (dorsal or plantar), anatomical location (toe, forefoot, midfoot, hind foot, ankle, or heel), and the positioning of the ulcer as lateral or medial located.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Off-loading type', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Boot', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'CAM boot', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Shoe', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'No off-loading', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Boot', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'CAM boot', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Shoe', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'No off-loading', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Number of debridements', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '3.54', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '3.34', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '3.43', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '4.09', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '3.85', 'groupId': 'BG001'}, {'value': '9.6', 'spread': '3.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'debridements', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Number of comorbidities', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '5.48', 'groupId': 'BG000'}, {'value': '7.9', 'spread': '4.29', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '4.92', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '4.50', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '4.32', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '4.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'All identified comorbidities from medical history.', 'unitOfMeasure': 'comorbidities', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: chronic kidney disease (CKD)', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: hypertension', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: peripheral arterial disease (PAD) / peripheral vascular disease (PVD)', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: chronic heart failure (CHF)', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: hyperlipidemia / dyslipidemia', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: gastroesophageal reflux disease (GERD)', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: hypothyroidism', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: lower extremity edema', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: peripheral neuropathy', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}, {'title': 'Comorbidities: any psychiatric condition', 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Both mITT and PP shown.'}], 'populationDescription': 'Both modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-12', 'size': 1225018, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-30T11:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2024-05-03', 'resultsFirstSubmitDate': '2025-10-09', 'studyFirstSubmitQcDate': '2024-05-03', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-23', 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Wound Healing', 'timeFrame': '12 weeks', 'description': 'The proportion of subjects achieving complete wound closure.'}], 'secondaryOutcomes': [{'measure': 'Percentage Area Reduction (PAR)', 'timeFrame': '12 weeks', 'description': 'Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination'}, {'measure': 'Time to Heal', 'timeFrame': '12 weeks', 'description': 'The time to achieve complete wound closure within 12 weeks.'}, {'measure': 'Changes in Quality of Life', 'timeFrame': '12 weeks', 'description': "The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes."}, {'measure': 'Change in Pain Level', 'timeFrame': '12 weeks', 'description': 'The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['DFU', 'Ulcer'], 'conditions': ['Diabetic Foot Ulcer', 'Ulcer Foot', 'Diabetic Foot']}, 'referencesModule': {'references': [{'pmid': '41014175', 'type': 'RESULT', 'citation': 'Armstrong DG, Orgill DP, Galiano RD, Lantis J, Glat PM, Gitterle M, Carter MJ, Young N, Zelen CM. A Borate-Based Bioactive Glass Advances Wound Healing in Non-Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial. Int Wound J. 2025 Oct;22(10):e70763. doi: 10.1111/iwj.70763.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.', 'detailedDescription': "This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.\n\nThere are two arms in the study:\n\nArm 1: SOC therapy (offloading of the DFU (CAM boots or total contact casting \\[TCC\\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with resorbable bioactive glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).\n\nARM 2: SOC therapy (offloading of the DFU (CAM boots or total contact casting \\[TCC\\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.\n3. At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with a photographic planimetry app.\n4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.\n7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:\n\n 1. TCOM ≥30 mmHg\n 2. ABI between 0.7 and 1.3\n 3. PVR: Biphasic\n 4. TBI ˃0.6\n 5. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle\n8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.\n10. The subject must consent to using the prescribed off-loading method for the duration of the study.\n11. The subject must agree to attend the weekly study visits required by the protocol.\n12. The subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. A subject known to have a life expectancy of \\< 6 months is excluded.\n2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.\n3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.\n4. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.\n6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.\n7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.\n8. If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.\n9. If a subject has a serum creatinine ≥ 3.0mg/dL within 6 months of randomization he/she is excluded.\n10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.\n11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.\n12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n13. A potential subject with end stage renal disease requiring dialysis is excluded.\n14. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.\n15. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.\n16. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded."}, 'identificationModule': {'nctId': 'NCT06403605', 'briefTitle': 'Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'ETS Wound Care, LLC'}, 'officialTitle': 'A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Borate-based Bioactive Glass Advanced Wound Matrix and Standard of Care Versus Standard of Care Alone', 'orgStudyIdInfo': {'id': 'ETS-MG-DFU-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOC primary dressing with MIRRAGEN™', 'description': 'Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.', 'interventionNames': ['Device: Mirragen Advanced Wound Matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOC primary dressing with FIBRACOL™', 'description': "A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.", 'interventionNames': ['Device: Fibracol']}], 'interventions': [{'name': 'Mirragen Advanced Wound Matrix', 'type': 'DEVICE', 'description': 'Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief.\n\nAdditional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing.\n\nMirragen Advanced Wound Matrix - application of Mirragen to wound site along with standard of care treatment.', 'armGroupLabels': ['SOC primary dressing with MIRRAGEN™']}, {'name': 'Fibracol', 'type': 'DEVICE', 'description': 'Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief.\n\nAdditional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing.\n\nFibracol - application of Fibracol to wound site along with standard of care treatment.', 'armGroupLabels': ['SOC primary dressing with FIBRACOL™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90010', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LA Foot and Ankle', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91769', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Casa Colina', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clincal Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33030', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Southernmost Foot and Ankle Specialists', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Doctor's Research Network", 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '62269', 'city': "O'Fallon", 'state': 'Illinois', 'country': 'United States', 'facility': 'Gateway Clinical Trials', 'geoPoint': {'lat': 38.59227, 'lon': -89.91121}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Foot and Ankle Center of Illinois', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '21703', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Foot and Ankle Specialists of the Mid Atlantic', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Wound Care Experts', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '44512', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lower Extremity Institute for Research and Therapy', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Wound Centrics', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'PULSE: Amputation Prevention Center, LLC', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '24153', 'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Foot and Ankle Specialists of the Mid Atlantic', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'zip': '98092', 'city': 'Auburn', 'state': 'Washington', 'country': 'United States', 'facility': 'United Wound Healing P.S', 'geoPoint': {'lat': 47.30732, 'lon': -122.22845}}], 'overallOfficials': [{'name': 'David Armstrong, DPM, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'USC/Salsa'}, {'name': 'Charles M Zelen, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professional Education and Research Institute'}, {'name': 'Robert Galiano, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Surgery, Plastic Surgery, Northwestern University School of Medicine, Chicago, IL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ETS Wound Care, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Professional Education and Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}