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Evaluating ENERGI-F703 GEL for diabetic foot ulcers

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

PHASE3 · Energenesis Biomedical Co., Ltd. · NCT05930210

This study is testing if a new gel can help heal diabetic foot ulcers that haven't improved for at least four weeks.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment230 (estimated)
Ages18 Years and up
SexAll
SponsorEnergenesis Biomedical Co., Ltd. (industry)
Locations24 sites (Miami, Florida and 23 other locations)
Trial IDNCT05930210 on ClinicalTrials.gov

What this trial studies

This Phase 3 study is designed to assess the efficacy and safety of ENERGI-F703 GEL in comparison to a vehicle control for patients suffering from Wagner Grade 1 to Grade 2 diabetic foot ulcers. Participants will be randomly assigned to receive either the active gel or a placebo in a double-blind manner, ensuring neither the participants nor the researchers know who receives which treatment. The study will last up to 31 weeks, including a screening phase, a 16-week treatment phase, and a 12-week safety follow-up. The study aims to determine if ENERGI-F703 GEL can promote healing in diabetic foot ulcers that have not healed for at least four weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with diabetes mellitus and non-healing diabetic foot ulcers classified as Grade 1 to Grade 2.

Not a fit: Patients with diabetic foot ulcers that are infected or necrotic will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with diabetic foot ulcers.

How similar studies have performed: Previous studies have shown promise in using similar topical treatments for diabetic foot ulcers, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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 use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence for the duration of the study and for 30 days after study treatment administration.
8. Female subjects are eligible only if all of the following apply:

   * Not pregnant with a negative serum pregnancy test at Screening visit and negative urine pregnancy test within 24 hours before randomization (test not required for females of non-childbearing potential, defined as surgically sterile \[eg, hysterectomy or bilateral oophorectomy\] or postmenopausal \[amenorrheic for at least 1 year\])
   * Not lactating
   * Not planning to become pregnant during the study
   * If of childbearing potential, commits to the use of a highly effective method of contraception for the duration of the study and at least 30 days after study treatment administration.

Exclusion Criteria:

1. History or evidence of osteomyelitis as confirmed by the investigator. An x-ray/pathology assessment of debridement or a probe-to-bone (PTB) test will be used to determine presence of osteomyelitis. However, participants who have a history or evidence of osteomyelitis in other parts of their body are eligible to participate in the study. If the medical history of osteomyelitis was cured by antibiotic therapy, surgery or amputation for more than 1 year, and no recurrence, no finding to the current leg and foot after testing, the participant can be enrolled
2. With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
3. Subjects with highly exudated wounds which require dressing changes more than 3 times a day may be enrolled, but heavily exudated wounds should not be selected as target ulcers
4. With poor nutritional status (serum albumin \<2g/dL or prealbumin \<10 mg/dL), poor diabetic control (hemoglobin A1c \>12%), a leukocyte counts \<2,000/mm3, abnormal liver function (aspartate aminotransferase, alanine aminotransferase \>3 x upper limit of normal range) within 21 days before Randomization visit
5. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
6. With known or suspected hypersensitivity to any ingredients of study product and vehicle
7. With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study (patients who have undergone peripheral angioplasty should be excluded unless the surgery was performed at least 30 days prior to screening)
8. Known or suspected history of drug abuse or a recent history of alcohol abuse (regularly drinks \>4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 6 months prior to screening (within 6 months prior to screening includes both drug abuse and alcohol abuse)
9. History or positive test results for HIV
10. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
11. Ankle brachial index \<0.8 or \>1.4
12. Enrollment in any investigational drug trial within 4 weeks before entering this study
13. With any condition judged by the investigator that entering the trial may be detrimental to the subject -

Where this trial is running

Miami, Florida and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetic Foot Ulcer, Foot Ulcer, Diabetes Mellitus, Wound, Wound Healing

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.