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

This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (\<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.

NCT Number	NCT05930210
Lead Sponsor	Energenesis Biomedical Co., Ltd.
Conditions	Diabetic Foot Ulcer, Foot Ulcer, Diabetes Mellitus, Wound
Enrollment	230 participants
Start Date	2023-05-30
Primary Completion	2025-12-30 (estimated)
Study Completion	2026-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-10-02