Tissue Repair Gel in Venous Leg Ulcers in AU/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)
TR Therapeutics
312 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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.
- History of cancer in the preceding 5 years (except as noted in the protocol).
- Participants considered nutritionally deficient.
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Interventions
6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
Standard of Care (wound cleansing/dressings and compression bandaging)
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06707103