Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-20 @ 7:04 AM
Study NCT ID:
NCT03796793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the genetic profile after debridement in the intervention group.', 'timeFrame': 'Baseline and 4 weeks', 'description': 'RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.'}], 'secondaryOutcomes': [{'measure': 'Percent rate of healing', 'timeFrame': 'Up to 4 weeks', 'description': 'Percent rate of healing is measured at every weekly visit and divided by 4 to calculate the average percent wound healing rate in cm2/week.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\>18 years of age\n2. Conformation of venous disease by non-invasive venous studies with either Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema)\n3. have a venous ulcer between the knee and ankle, at or above the malleolus\n4. wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone\n5. wound duration of at least 6 months\n6. VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue\n7. ability of subject to tolerate limb compression bandage\n\nExclusion Criteria:\n\n1. history of diabetes mellitus and a HbA1c \\> 12% (obtained within past 6 months)\n2. Ankle brachial index(ABI) less than 0.80\n3. any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years\n4. suspicion of malignancy within VLU\n5. life expectancy \\<6 months\n6. history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months)\n7. history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) \\>2x upper limit of normal (obtained within past 6 months)\n8. requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry\n9. history of immunodeficiency\n10. ulcers due to none venous etiology and leg ulcers associated with mixed etiology\n11. Untreated osteomyelitis\n12. Hepatitis\n13. acute deep venous thrombosis\n14. allergy to lidocaine and/or epinephrine\n15. Subject's inability to successfully tolerate compression therapy that is changed weekly\n16. Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors)\n17. if currently incarcerated\n18. known pregnancy"}, 'identificationModule': {'nctId': 'NCT03796793', 'briefTitle': 'Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers', 'orgStudyIdInfo': {'id': '20180256'}, 'secondaryIdInfos': [{'id': 'R01AR073614', 'link': 'https://reporter.nih.gov/quickSearch/R01AR073614', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wound Edge Debridement Group', 'description': 'Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.', 'interventionNames': ['Procedure: Wound Edge Debridement', 'Other: Standard of Care Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care group', 'description': 'Participants in this group will receive only the standard care of treatment for up to 4 weeks.', 'interventionNames': ['Other: Standard of Care Treatment']}], 'interventions': [{'name': 'Wound Edge Debridement', 'type': 'PROCEDURE', 'description': 'Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.', 'armGroupLabels': ['Wound Edge Debridement Group']}, {'name': 'Standard of Care Treatment', 'type': 'OTHER', 'description': 'Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.', 'armGroupLabels': ['Standard care group', 'Wound Edge Debridement Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Marjana Tomic-Canic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Robert Kirsner, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Chairman', 'investigatorFullName': 'Robert S. Kirsner', 'investigatorAffiliation': 'University of Miami'}}}}