Phase 3 Study of TR987 0.1% Gel Plus Standard Care Versus Standard Care Alone for Treating Chronic Venous Leg Ulcers

What this Trial Is About

Researchers are evaluating whether TR987 0.1% gel combined with Standard of Care is more effective than Standard of Care alone for treating Venous Leg Ulcers VLUs. This Phase 3, outpatient, randomized, double-blind study focuses on participants with non-healing VLUs to assess the drugs efficacy and safety over 16 weeks. Participants are assigned to one of two groups one receiving TR987 0.1% gel plus Standard of Care, and the other receiving Standard of Care alone. The gel is applied topically twice weekly for the first four weeks, then weekly for the remaining 12 weeks. Standard of Care includes wound cleansing, dressings, and compression bandaging throughout the treatment period. During the study, participants will be regularly assessed for ulcer closure, pain levels, and changes in ulcer size at 12 and 16 weeks. The primary measure is the proportion of participants with complete ulcer closure by Week 16. Secondary outcomes include sustained closure at 3 months, pain reduction, and significant ulcer size reduction. Safety and tolerability are also monitored throughout the study period.

Tissue Repair Gel in Venous Leg Ulcers (US)