Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05092620
Status:
TERMINATED
Last Update Posted:
2024-07-24
First Post:
2021-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma, serum, urine, wound tissue, wound dressing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The Diabetic Foot Consortium studies that fed into the biorepository study were completed (TEWL) and halted prematurely (CMYC), while another DFC study was opened that collected the biospecimens that were previously collected in this study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants consenting', 'timeFrame': 'Up to 2 years', 'description': 'Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall'}, {'measure': 'Biospecimens collected', 'timeFrame': 'Up to 2 years', 'description': 'Proportion of biospecimens collected, by type, from among those expected, by study and overall'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes, diabetic foot ulcer, DFU, wound, wound healing'], 'conditions': ['Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.', 'detailedDescription': 'Participants enrolling in a parent DFC research study will be concurrently approached about participating in the DFC Biorepository as well. If agreeable, participants will be asked to provide blood, urine, wound debridement tissue and wound dressing samples at the time of enrollment and once more if appropriate and as coincides with the primary study visit schedule. Participants will also be contacted via phone for every six months for two years thereafter to gather longitudinal data about their wound. Data and samples from the Biorepository, along with data collected during the primary study will be available to ancillary researchers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult diabetic patients with diabetic foot ulcer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provides written informed consent\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age \\> 18 years\n* Previous diagnosis of Type 1 or Type 2 diabetes or pre-diabetes per American Diabetes Association (ADA) guidelines\n* Inclusion in a part of any planned or approved DFC protocol\n\nExclusion Criteria:\n\n* An individual who meets exclusion criteria of the primary DFC protocol in which they are enrolled will also be excluded from participation in the biorepository program as well.'}, 'identificationModule': {'nctId': 'NCT05092620', 'briefTitle': 'Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials', 'orgStudyIdInfo': {'id': 'HUM00193015'}, 'secondaryIdInfos': [{'id': '5U24DK122927-03', 'link': 'https://reporter.nih.gov/quickSearch/5U24DK122927-03', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Brian Schmidt, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Cathie Spino, ScD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indiana University', 'class': 'OTHER'}, {'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor of Biostatistics, SABER Director', 'investigatorFullName': 'Cathie Spino, ScD', 'investigatorAffiliation': 'University of Michigan'}}}}