Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-30 @ 8:30 PM
Study NCT ID:
NCT06707103
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2024-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Repair Gel in Venous Leg Ulcers in AU/US
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005782', 'term': 'Gels'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Particpants will be randomized to either TR987 1% gel + Standard of Care and Standard of Care alone. Sponsor, particpant, and Investigator/Outcomes Assessor will be masked throughout the treatment period.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-24', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.', 'timeFrame': '16 weeks', 'description': 'Patient count'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).', 'timeFrame': '16 weeks', 'description': 'Patient count'}, {'measure': "Change from baseline in participant's perception of pain level at 12 weeks.", 'timeFrame': '12 weeks', 'description': 'Pain to be measured on a 10 point numeric rating scale'}, {'measure': 'Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.', 'timeFrame': '12 and 16 weeks', 'description': 'Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change'}, {'measure': 'Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.', 'timeFrame': '12 weeks', 'description': 'Count the number of patients with complete closure and divide by the total number of patients'}, {'measure': 'Proportion of participants with any significant reduction in pain at or before 12 weeks.', 'timeFrame': '12 weeks', 'description': 'Count the number of patients with any significant reduction in pain and divide by the total number of patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tissue Repair', 'Glucoprime', 'TR Therapeutics', 'Debridement', 'VLU'], 'conditions': ['Venous Leg Ulcer', 'Venous Ulcer', 'Venous Stasis Ulcer', 'Venous Stasis', 'Wound Heal', 'Wound', 'Venous Insufficiency of Leg', 'Non-healing Wound']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.triviastudy.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.', 'detailedDescription': "This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).\n\nThe primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.\n\nSecondary endpoints include:\n\n* Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint).\n* Change from baseline in participant's perception of pain level at 12 weeks.\n* Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.\n* Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit.\n* Proportion of participants with any significant reduction in pain at or before 12 weeks.\n\nThere are also some supplementary and safety endpoints."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg/m2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* History of cancer in the preceding 5 years (except as noted in the protocol).\n* Participants considered nutritionally deficient.'}, 'identificationModule': {'nctId': 'NCT06707103', 'acronym': 'TRIVIA', 'briefTitle': 'Tissue Repair Gel in Venous Leg Ulcers in AU/US', 'organization': {'class': 'INDUSTRY', 'fullName': 'TR Therapeutics'}, 'officialTitle': 'A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)', 'orgStudyIdInfo': {'id': 'BG003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TR987 0.1% gel + Standard of Care', 'description': 'Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.', 'interventionNames': ['Drug: TR987 0.1% gel + Standard of Care']}, {'type': 'OTHER', 'label': 'Standard of Care', 'description': 'Participants will receive Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'TR987 0.1% gel + Standard of Care', 'type': 'DRUG', 'otherNames': ['Glucoprime'], 'description': '6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)', 'armGroupLabels': ['TR987 0.1% gel + Standard of Care']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Standard of Care (wound cleansing/dressings and compression bandaging)', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clincial Research Site 92', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '48038', 'city': 'Clinton Twp', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clincial Research Site 77'}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clincial Research Site 82', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site 76', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clincial Research Site 62', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clinical Research Site 84', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2800', 'city': 'Orange', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clincial Research Site 78', 'geoPoint': {'lat': -33.28397, 'lon': 149.10018}}, {'zip': '2065', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clincial Research Site 85', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3550', 'city': 'Bendigo', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clincial Research Site 74', 'geoPoint': {'lat': -36.75818, 'lon': 144.28024}}, {'zip': '3079', 'city': 'Ivanhoe', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clincial Research Site 60', 'geoPoint': {'lat': -37.76903, 'lon': 145.04308}}, {'zip': '3630', 'city': 'Shepparton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clincial Research Site 65', 'geoPoint': {'lat': -36.38047, 'lon': 145.39867}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'info@trtherapeutics.com'}], 'facility': 'Clincial Research Site 75', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'centralContacts': [{'name': 'Anhthu Nguyen Vice President, Global Clinical Operations', 'role': 'CONTACT', 'email': 'anhthu.nguyen@trtherapeutics.com', 'phone': '(+61) 280 034 554'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If clinical trial data will be published, this relevant information may be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TR Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}