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

What this Trial Is About

Researchers are studying participants with chronic Venous Leg Ulcers VLUs to see if adding TR987 0.1% gel to the Standard of Care improves healing compared to Standard of Care alone. This Phase 3, randomized, double-blind trial aims to evaluate the effectiveness and safety of the TR987 gel in treating VLUs, a type of non-healing wound caused by venous insufficiency. Participants will be assigned to one of two groups one group will receive TR987 0.1% gel applied topically along with Standard of Care treatments like wound cleansing, dressings, and compression bandaging the other group will receive Standard of Care alone. Treatments will be applied twice weekly for the first four weeks, then once weekly for the following 12 weeks, totaling up to 16 weeks of treatment. During the study, participants will have their target ulcer monitored for complete closure at various time points, including the 12- and 16-week marks, as well as follow-up at three months after closure. Pain levels and changes in ulcer size will also be assessed. Safety and tolerability will be tracked throughout the trial. Participation involves regular visits for treatment and evaluation over the 16-week treatment period, with additional follow-up to assess lasting ulcer closure.

Tissue Repair Gel in Venous Leg Ulcers in AU/US