Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 3:02 AM
Study NCT ID:
NCT01070433
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2010-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'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'}]}, '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2015-05-18', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2010-02-16', 'dispFirstSubmitQcDate': '2015-05-18', 'studyFirstSubmitQcDate': '2010-02-17', 'dispFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of complete healing of the target ulcer.', 'timeFrame': '8 week treatment period'}], 'secondaryOutcomes': [{'measure': 'Time required to achieve complete healing (days).', 'timeFrame': '8 week treatment period'}, {'measure': 'Absolute and percentage change in ulcer surface area from baseline to endpoint.', 'timeFrame': '8 week treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic Foot Ulcers (DFUs)'], 'conditions': ['Diabetic Foot Ulcers']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).', 'detailedDescription': 'This is a phase II, randomized, controlled, multi-center study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Able and willing to provide informed consent\n* Able and willing to comply with protocol visits and procedures\n* Target ulcer duration of ≥4 weeks\n\nExclusion Criteria:\n\n* Ulcer of a non-diabetic pathophysiology\n* Known or suspected allergies to any of the components of MEBO\n* Malignancy on target ulcer foot\n* Non-compliance in the screening or run-in period'}, 'identificationModule': {'nctId': 'NCT01070433', 'briefTitle': 'A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Skingenix, Inc.'}, 'officialTitle': 'A Phase II, Randomized, Controlled, Multi-Center Study of the Safety and Efficacy of Topically Applied MEBO Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'MEBO-DFU-PII-001 v. 4.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEBO Wound Ointment (MEBO)', 'description': 'Topical application twice a day', 'interventionNames': ['Drug: MEBO Wound Ointment (MEBO)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Topical application twice a day', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'MEBO Wound Ointment (MEBO)', 'type': 'DRUG', 'otherNames': ['MEBO'], 'description': 'Topical application twice a day', 'armGroupLabels': ['MEBO Wound Ointment (MEBO)']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Topical application twice a day', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clinical Research, Inc.', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'ILD Consulting, Inc.', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '95628', 'city': 'Fair Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento Foot and Ankle Center', 'geoPoint': {'lat': 38.64463, 'lon': -121.27217}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Vascular Surgery Associates', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90010', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Foot and Ankle Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Advanced Foot and Ankle Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '78501', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Complete Family Foot Care', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials, San Antonio Podiatry Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Robert S Kirsner, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skingenix, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}