A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer (NCT05930210)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: A and D Doctor Center — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- A and D Doctor Center — Miami, Florida
- Bioclinical Research — Miami, Florida
- Reliant Medical Research — Miami, Florida
- Advanced Medical Research Institute — Miami, Florida
- New Horizons Research — Palmetto Bay, Florida
- IACT Health — Columbus, Georgia
- The Jackson Clinic PA — Jackson, Tennessee
- Mt. Olympus Medical Research — Houston, Texas
- Wasatch Clinical Research — Salt Lake City, Utah
- Salem Veterans Affairs Medical Center VAMC — Salem, Virginia
- Ditmanson Medical Foundation Chia-Yi Christian Hospital — Chiayi City,
- Kaohsiung Medical University Hospital — Kaohsiung City,
- China Medical University Hospital — Taichung,
- Kung Tien General Hospital — Taichung,
- Taichung Veterans General Hospital — Taichung,
- Chi Mei Medical Center — Tainan,
- National Cheng Kung University Hospital — Tainan,
- Cathay General Hospital — Taipei,
- MacKay Memorial Hospital — Taipei,
- National Taiwan University Hospital — Taipei,
- Shin Kong Wu Ho Su Memorial Hospital — Taipei,
- Taipei Veterans General Hospital — Taipei,
- Tri-Service General Hospital — Taipei,
- Linkou Chang Gung Memorial Hospital — Taoyuan,
📞 Contact the Study Coordinator
Phone: +886-2-26270835
Email: ct@energenesis-biomedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Foot Ulcer
- Omega3 Wound Fish Skin Graft in the Treatment of DFUs — Coconut Creek, Florida
- At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers — Baltimore, Maryland
- A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot — San Francisco, California
- Efficacy of ProgenaMatrix™ in the Management of DFUs — Puyallup, Washington
- Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management — Palm Springs, California
- NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers — Phoenix, Arizona
Explore by condition: All Diabetic Foot Ulcer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.