Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-02 @ 1:21 PM
Study NCT ID:
NCT07078968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A REAL WORLD DATA COLLECTION OF HUMAN AMNIOTIC MEMBRANE(S) ON DIABETIC FOOT ULCERS, VENOUS LEG ULCERS, PRESSURE ULCERS AND POST OPERATIVE WOUNDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'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': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of wound closure by or on week 16', 'timeFrame': '16 weeks', 'description': 'Wound closure is defined as: Full epithelialization of the wound with the absence of drainage. Epithelialization is defined as a layer of epithelium visible on the wound surface'}], 'secondaryOutcomes': [{'measure': 'Wound improvement by or on End of Study (EOS) from baseline', 'timeFrame': '16 weeks', 'description': 'Defined by: \\>60% reduction in area, or \\>60% reduction in depth, or \\>75% reduction in volume'}, {'measure': 'Incidence of wound recurrence within the 16-week study period', 'timeFrame': '16 weeks', 'description': 'Incidence of wound recurrence within the 16-week study period'}, {'measure': 'Mean number of wound free days within the 16-week study period', 'timeFrame': '16 weeks', 'description': 'Mean number of wound free days within the 16-week study period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer (VLU)', 'Diabetic Foot Ulcer (DFU)', 'Pressure Ulcer (PU)']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.', 'detailedDescription': 'This is a retrospective multi-center study collecting real world evidence on the use of Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ and Standard of Care alone in subjects with eligible DFUs, VLUs, PUs, and post operative wounds that have not healed with conventional therapy for greater than or equal to 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with difficult to heal partial- or full-thickness diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure ulcers (PU), and post-operative wounds defined as an ulcer that has not healed with conventional therapy for ≥ 4 weeks.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds\n2. Subject has retrospectively been treated with Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ or Subject has retrospectively been treated with Standard of Care only.\n3. Subjects should have been treated from January 2022 to present day.\n\nExclusion Criteria:\n\n1. Subjects that did not have a wound closure verification appointment.\n2. Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.'}, 'identificationModule': {'nctId': 'NCT07078968', 'briefTitle': 'A REAL WORLD DATA COLLECTION OF HUMAN AMNIOTIC MEMBRANE(S) ON DIABETIC FOOT ULCERS, VENOUS LEG ULCERS, PRESSURE ULCERS AND POST OPERATIVE WOUNDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioLab Holdings'}, 'officialTitle': 'A REAL WORLD DATA COLLECTION OF HUMAN AMNIOTIC MEMBRANE(S) ON DIABETIC FOOT ULCERS, VENOUS LEG ULCERS, PRESSURE ULCERS AND POST OPERATIVE WOUNDS', 'orgStudyIdInfo': {'id': 'RWE-001-25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 Amniotic Membrane', 'description': "De-Identified subject data will be extracted from investigators' medical records for subjects who received Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ plus SOC in subjects with eligible DFUs, VLUs, PUs and post operative wounds", 'interventionNames': ['Device: Tri-Membrane Wrap™', 'Device: Membrane Wrap™', 'Device: Membrane Wrap-Hydro™']}, {'label': 'Group 2 SOC', 'description': "De-identified subject data will be extracted from investigators' medical records who were treated with only Standard of Care with eligible DFUs, VLUs, PUs and post operative wounds. Subjects in the SOC may have received hyperbaric or wound vac therapies as part of their treatments.", 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Tri-Membrane Wrap™', 'type': 'DEVICE', 'description': 'Membrane Wrap™', 'armGroupLabels': ['Group 1 Amniotic Membrane']}, {'name': 'Membrane Wrap™', 'type': 'DEVICE', 'description': 'Membrane Wrap™', 'armGroupLabels': ['Group 1 Amniotic Membrane']}, {'name': 'Membrane Wrap-Hydro™', 'type': 'DEVICE', 'description': 'Membrane Wrap-Hydro™', 'armGroupLabels': ['Group 1 Amniotic Membrane']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Basic care involves debridement, along with local wound care depending on the wound needs. Debridement involves removal of fibrin and devitalized tissue from the base and the borders of the ulcer which is necessary in all treatment plans to reduce the risk of infection and promote healing.', 'armGroupLabels': ['Group 2 SOC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85048', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Athena Specialty Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Revive Advanced Wound Care', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Foot and Ankle Care', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77095', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Foot Dr', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Marshall Medley', 'role': 'STUDY_CHAIR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioLab Holdings', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}