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Tissue Repair Gel in Venous Leg Ulcers (US)
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)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Adults 18 years and older * Venous insufficiency has been clinically diagnosed clinically and medically confirmed. * Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control. * The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization. * Target ulcer age must be ≥ 4 weeks at Screening. * Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler. * Body mass index (BMI) ≤ 50 kg/m2. * HbA1C ≤12%. Exclusion Criteria: * Target ulcer has been treated with prohibited medications or therapies. * History of radiation at the target ulcer site. * Target ulcer decreases in area by 30% or more during screening period. * History of osteomyelitis at the target ulcer within 6 months of screening. * Participants considered nutritionally deficient.
About the study
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.
What is being tested
- TR987 0.1% gel + Standard of Care (drug)
- Standard of care (other)
Sponsor: TR Therapeutics · Participants: 312 · Started: Jan 28, 2025
Contact the study team
- Anhthu Nguyen Vice President, Global Clinical Operations · Phone: (+61) 280 034 554
Official record on ClinicalTrials.gov — NCT06707090
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.