Picayune

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating diabetic foot ulcers. This randomized controlled crossover trial is open label and takes place across multiple medical centers. The study aims to gather information on wound healing rates and support insurance reimbursement decisions by measuring complete wound closure and other wound-related outcomes. Participants will be randomly assigned to receive either standard care alone or standard care plus weekly NeoThelium FT applications. Standard care includes wound cleansing, sharps debridement, moisture balancing dressings, and offloading. Subjects in the standard care group who do not achieve complete wound closure by day 84 may cross over to receive NeoThelium FT with standard care for up to 12 weekly treatments. The study includes a two-week screening phase before randomization. Participants will undergo regular wound assessments, pain evaluations on specific days, and follow-up visits according to the study schedule. Researchers will monitor wound healing progress including wound area changes and time to closure. The primary outcome is the percentage of ulcers completely closed within 12 weeks. Secondary outcomes include wound area reduction and pain assessments. The trial is expected to run until October 2026.