A Randomized, Double-Blind, Vehicle-Controlled Phase III Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness and safety of ENERGI-F703 GEL in treating diabetic foot ulcers classified as Wagner Grade 1 to Grade 2. This Phase 3, randomized, double-blind, vehicle-controlled study includes participants with ulcers of different sizes and aims to compare the gel against a vehicle control across multiple centers. The total study duration is up to 31 weeks, encompassing screening, treatment, and safety follow-up phases. Participants will be randomly assigned to receive either ENERGI-F703 GEL or a matching vehicle gel, both applied topically twice daily for 16 weeks. The study uses a web-based system to assign participants to one of the two groups. After the treatment phase, a 12-week safety follow-up is conducted to monitor participants. Initial screening lasts approximately 2 to 3 weeks before treatment begins. Throughout the study, participants undergo regular assessments including evaluation of ulcer closure rates at week 16, and monitoring of ulcer healing progress at multiple time points. Safety is tracked by recording adverse events from week 1 through week 28. Participants will have visits to assess wound status, adverse events, and overall health, with the primary outcome being the complete closure of the ulcer by week 16.

A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer