Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 4:43 AM
Study NCT ID:
NCT01270633
Status:
TERMINATED
Last Update Posted:
2017-12-02
First Post:
2011-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2011-01-04', 'studyFirstSubmitQcDate': '2011-01-04', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of study ulcers healed', 'timeFrame': '12 weeks post-randomization', 'description': 'Percent of study ulcers healed at week 12 post-randomization'}], 'secondaryOutcomes': [{'measure': 'Cost of Treatment', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Foot Ulcer, Diabetic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.', 'detailedDescription': 'Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women ≥ 18 years of age and able to give their own consent\n* Type I or Type II diabetes with investigator-confirmed reasonable metabolic control\n* Study ulcer has a Wagner grade of 1 or 2\n* Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement\n* A full thickness diabetic foot ulcer located on the foot or ankle\n* An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.\n\nExclusion Criteria:\n\n* Suspected or confirmed signs/symptoms of wound infection\n* Wounds with exposed bone or tendon\n* Hypersensitivity to bovine collagen'}, 'identificationModule': {'nctId': 'NCT01270633', 'briefTitle': 'A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'TEI-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.', 'interventionNames': ['Device: PriMatrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'PriMatrix', 'type': 'DEVICE', 'description': 'Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy', 'armGroupLabels': ['Treatment']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Following sharp debridement, moist wound therapy', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30041', 'city': 'Cumming', 'state': 'Georgia', 'country': 'United States', 'facility': 'HyperbaRXs', 'geoPoint': {'lat': 34.20732, 'lon': -84.14019}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Covenant Medical Center', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '00918', 'city': 'San Juan', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Caribbean Clinical Trials', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00717', 'city': 'Guaynabo', 'country': 'Puerto Rico', 'facility': 'Professional Hospital', 'geoPoint': {'lat': 18.35745, 'lon': -66.111}}, {'zip': '00717', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Dr. Pila Metropolitan Hospital Wound Healing Center', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': "Doctors' Center Hospital of San Juan", 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Wound and Ulcer Care Clinic of San Juan', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00694', 'city': 'Vega Baja', 'country': 'Puerto Rico', 'facility': 'Wilma N. Vazquez Hospital', 'geoPoint': {'lat': 18.44439, 'lon': -66.38767}}], 'overallOfficials': [{'name': 'Yiannis Monovoukas, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'TEI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}