Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-01-29 @ 8:25 PM
Study NCT ID:
NCT02813161
Status:
UNKNOWN
Last Update Posted:
2018-05-03
First Post:
2016-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diabetic Foot Ulcer Registry
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'C117898', 'term': 'Apligraf'}, {'id': 'C512800', 'term': 'TransCyte'}, {'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}, {'id': 'D003646', 'term': 'Debridement'}, {'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}, {'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '6 months', 'description': 'wound closure'}, {'measure': 'major amputation', 'timeFrame': '6 months', 'description': 'above the knee, below the knee'}, {'measure': 'minor amputation with preservation of ambulation', 'timeFrame': '6 months', 'description': 'toe amputation, transmetatarsal'}, {'measure': 'Death', 'timeFrame': '6 months', 'description': 'death without wound closure'}], 'secondaryOutcomes': [{'measure': 'Patient Quality of life', 'timeFrame': '12 weeks', 'description': 'W-QoL score'}, {'measure': 'Patient Reported Outcome', 'timeFrame': '12 months', 'description': 'using patient reported outcome quality measure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetic foot ulcer', 'diabetes', 'arterial disease', 'neuropathy', 'amputation', 'QCDR', 'quality measure', 'wound'], 'conditions': ['Diabetic Foot Ulcer Outcome', 'Quality of Patient Care']}, 'descriptionModule': {'briefSummary': 'This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.', 'detailedDescription': 'This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National benchmarking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospectively followed diabetic foot ulcers in the practice of clinicians submitting data to the registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with diabetic foot ulcers seen by the practitioner\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02813161', 'acronym': 'DFUR', 'briefTitle': 'The Diabetic Foot Ulcer Registry', 'organization': {'class': 'OTHER', 'fullName': 'U.S. Wound Registry'}, 'officialTitle': 'A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice', 'orgStudyIdInfo': {'id': 'CDR005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cellular and tissue based therapy', 'type': 'BIOLOGICAL', 'otherNames': ['Apligraf', 'Dermagraft', 'Theraskin', 'Epifix', 'Dermapure', 'Graffix', 'Talymed']}, {'name': 'negative pressure wound therapy', 'type': 'DEVICE', 'otherNames': ['The VAC', 'Pico', 'SnAP']}, {'name': 'debridement', 'type': 'PROCEDURE'}, {'name': 'advanced wound therapy', 'type': 'PROCEDURE'}, {'name': 'Nutritional screening', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'off-loading', 'type': 'DEVICE', 'otherNames': ['TCC EZ-Cast', 'Total Contact Casting', 'CROW walker', 'shoe modification']}, {'name': 'Hyperbaric oxygen Therapy', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sherrill White Wolfe', 'role': 'CONTACT', 'email': 'swhitewolfe@StLukesHealth.org', 'phone': '936-266-2150'}], 'facility': "CHI St. Luke's The Woodlands", 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'centralContacts': [{'name': 'Monica Weir, MBA, CCRP', 'role': 'CONTACT', 'email': 'monica.weir@uswoundregistry.com', 'phone': '(800) 603-7896'}, {'name': 'Caroline E Fife, MD', 'role': 'CONTACT', 'email': 'cfife@uswoundregistry.com', 'phone': '(800) 603-7896'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Wound Registry', 'class': 'OTHER'}, 'collaborators': [{'name': 'APMA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}