NCT05930210

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

A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase III Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Diabetic Foot Ulcers

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Energenesis Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Foot Ulcer
• Foot Ulcer
• Diabetes Mellitus
• Wound

Interventions

Type	Name	Description
DRUG	ENERGI-F703 GEL	Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
DRUG	ENERGI-F703 matched vehicle	Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-12-30
• Completion: 2026-03-31
• First posted: 2023-07-05
• Last updated: 2025-10-02

Locations

24 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study