NCT05930210 · Energenesis Biomedical Co., Ltd.
A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
What this study is about
This Phase 3 study is a randomly assigned, where neither patients nor doctors know which treatment is given, vehicle-controlled, multiple-center, parallel study to evaluate effectiveness and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers.
View original scientific description
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.
Interventions
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.
Primary outcome measures
The ulcer complete closure rate
Time frame: Weeks 16
Proportion of subjects with a recording of complete ulcer closure at Week 16 (the end of the treatment period) as assessed by the investigator, where such closure is subsequently confirmed at 2 consecutive study visits over a 2-week period (ie, by Week 18). A complete ulcer closure is defined as 100% skin re epithelialization without drainage or dressing requirements.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject must be at least 18 years old. 2. Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DM medication treatment or subjects with naïve DM with duplicated hemoglobin A1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least 1 week apart before screening. 3. Subject must have at least 1 cutaneous ulcer on the foot and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If 2 or more ulcers have the largest size, the one with worst grade will be selected. If 2 or more ulcers have the largest size and grade, the one with longest duration will be selected. 4. The target ulcer is classified as Grade 1 to Grade 2 ulcer according to Wagner Grading System and with ulcer size of 1.5 cm2 to 25 cm2. 5. Diabetic foot ulcers should be free of any necrosis or infection 6. Subject has signed the written informed consent form 7. Male subjects must be surgically sterile or commit to the
Where
- Miami, Florida
- Palmetto Bay, Florida
- Columbus, Georgia
- Jackson, Tennessee
- Houston, Texas
- Salt Lake City, Utah
- Salem, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2025 · Source of record for eligibility and locations