Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-07 @ 3:36 PM
Study NCT ID:
NCT02463500
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D010019', 'term': 'Osteomyelitis'}], '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'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, bone and tissue samples will be banked in the UT Southwestern Department of Plastic Surgery Laboratory and tested for bacteria, biomarkers, inflammatory cytokines and other indicators of infection.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Healing', 'timeFrame': '12 Weeks', 'description': 'Wound healing defined as fully epithelialized over the base.'}, {'measure': 'Biomarkers', 'timeFrame': '2 Years', 'description': 'Quantity and types of biomarkers in blood, tissue and bone specimens'}, {'measure': 'Adverse Events', 'timeFrame': '1 Years', 'description': 'Number and type of adverse events, severity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcers', 'Osteomyelitis']}, 'descriptionModule': {'briefSummary': 'This will be a continuing, prospective study of diabetic foot ulcers and infections, risk factors and clinical outcomes and a limited data set conducted by the investigator through the establishment of a data and tissue repository in the uT Southwestern Department of Plastic Surgery. in addition, subjects consented for this research will be asked about inclusion in a recruitment database to be used in the recruitment of subjects for future research on diabetic foot complications.\n\nabout 250 patients are seen for diabetic foot ulcers and infections each year.', 'detailedDescription': "Subjects will be consented during a scheduled visit for standard care at the Clements University Hospital, UT Southwestern Wound Clinic, Parkland Hospital or the Parkland ASC Wound Clinic. There will be 2 study visits: Baseline and operating room visit. At the time of scheduled procedures or laboratory blood draws (as part of standard of care or SOC), soft tissue (from wound debridement or surgery), and bone if possible (from surgery or bone biopsy) will be obtained for histological sectioning and/or laboratory analysis. Tissue and or bone (surgical waste will be sent to the plastic surgery laboratory for storage and analysis.\n\nTissues with or without bone will be sent to the clinical pathology core for paraffin/frozen sectioning. Histological sections will be used for immunostaining and laser capture microdissection to evaluate tissue ultrastructure and region /cell specific gene expression analysis. Samples will also be sent to the Research and Testing Laboratory in Lubbock, TX for bacterial analysis and to Dermagenesis, LLC in Pompano Beach, FL for isolation of cellular components from different wound specimens and to define characteristics such as proliferation and migration rates. Bone (surgical waste) will also be sent to the 1st Department of Internal Medicine, Laiko General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece, for isolation of cellular components and cytokine analysis. In case infected bone is collected during surgery, it will be fixed and processed in the imaging core laboratory of our facility to evaluate biofilm with a Scanning Electron Microscope.\n\nRelevant information obtained from the medical record will include age, gender, ethnicity, size (dimensions) of ulcer, location of ulcer, duration of ulcer, results of neurological and vascular testing, medical comorbidities, social history, laboratory data, offloading, and history of prior treatment (limited data set with no personal identifying information). Patient information will be de-identified and assigned a code. Bone and tissue samples will be banked in the UT Southwestern Department of Plastic Surgery Laboratory and tested for bacteria, biomarkers, inflammatory cytokines and other indicators of infection. All samples will be kept under the control of the principal investigator and used until exhausted. We will also follow these subjects for two (2) years to identify incidents of care and hospital readmissions for diabetic foot complications through review of the subject's electronic medical record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the investigators. Male and female, age 18 and older (up to age 89), of any race or ethnicities, who have diabetes (Type I or II) and a foot ulceration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients of the investigators. Male and female, age 18 and older (up to age 89), of any race or ethnicities, who have diabetes (Type I or II) and a foot ulceration.-\n\nExclusion Criteria:\n\n* Not meeting Inclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT02463500', 'acronym': 'DFUDatabase', 'briefTitle': 'UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository', 'orgStudyIdInfo': {'id': '18776'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DFU with/without osteomyelitis', 'description': 'Patients of the investigators. Male and female, age 18 and older (up to age 89), of any race or ethnicities, who have diabetes (Type I or II) and a foot ulceration.', 'interventionNames': ['Other: DFU']}], 'interventions': [{'name': 'DFU', 'type': 'OTHER', 'description': 'Standard care.', 'armGroupLabels': ['DFU with/without osteomyelitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390-9132', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Lawrence Lavery, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Parkland Health and Hospital System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Plastic Surgery', 'investigatorFullName': 'Larry Lavery', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}