D'Iberville

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard wound care compared to standard care alone in treating chronic open wounds. This randomized controlled crossover trial involves patients with chronic open wounds that have not healed sufficiently, aiming to assess wound closure rates within 12 weeks. The study is open label and conducted at multiple medical centers, supporting post-marketing evaluation and insurance reimbursement decisions. Participants will be randomly assigned to receive either standard care alone or standard care plus weekly NeoThelium FT applications. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT with standard care for up to 12 additional weekly treatments. Standard care includes wound cleansing, debridement, moisture-balancing dressings, and offloading. Before randomization, participants undergo a two-week screening phase. Throughout the study, wound healing progress and pain levels are regularly assessed, including wound area measurements and pain evaluations at specified time points. The primary measurement is the rate of complete wound closure within 12 weeks, with secondary outcomes assessing wound size reduction and pain. The study duration extends through treatment and follow-up visits, concluding by October 2026.

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.