D'Iberville

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard of care compared to standard of care alone in treating chronic open wounds. This randomized controlled crossover trial is open label, meaning both researchers and participants know which treatment is given. The study aims to collect information on wound healing and pain while supporting insurance reimbursement decisions across multiple medical centers. Participants will be randomly assigned to one of two groups: standard of care (SOC) alone or SOC plus NeoThelium FT. Those in the SOC group who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT along with SOC for up to 12 weekly treatments. Treatments include wound cleansing, debridement, dressings, and offloading, with NeoThelium FT being a special membrane derived from donated human placental tissue. Participants will undergo a two-week screening before randomization and then receive treatments and follow-up visits for up to 12 weeks. Assessments include measuring wound closure, wound size reduction, and pain levels at multiple time points. Researchers will monitor wound healing progress and safety throughout the study, which may last several months depending on individual response and crossover status.

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 drug's 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.