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New gel could speed healing of diabetic foot sores

NCT ID NCT05930210

Disease control Sponsor: Energenesis Biomedical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tests whether a gel called ENERGI-F703 can help close diabetic foot ulcers better than a placebo gel. About 230 adults with diabetes and a foot ulcer that hasn't healed for at least 4 weeks will receive either the active gel or a placebo, along with standard wound care. The main goal is to see if the ulcer fully closes within 16 weeks and stays closed for at least 2 more weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ENERGI-F703 gel
What this could lead to
If it works, this gel could help heal diabetic foot ulcers faster and more completely, reducing the risk of infection or amputation.
What could go wrong
This is a Phase 3 trial, but results are not guaranteed. The gel may not work better than standard care, and some people may have skin reactions or no improvement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 -

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot Foot Ulcer injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Diabetic foot ulcer Foot ulcer Wound

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A and D Doctor Center

    RECRUITING

    Miami, Florida, 33135, United States

  • Advanced Medical Research Institute

    RECRUITING

    Miami, Florida, 33174-3201, United States

  • Bioclinical Research

    RECRUITING

    Miami, Florida, 33155, United States

  • Cathay General Hospital

    RECRUITING

    Taipei, Taiwan

  • Chi Mei Medical Center

    RECRUITING

    Tainan, Taiwan

  • China Medical University Hospital

    RECRUITING

    Taichung, Taiwan

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    RECRUITING

    Chiayi City, Taiwan

  • IACT Health

    RECRUITING

    Columbus, Georgia, 31904, United States

  • Kaohsiung Medical University Hospital

    RECRUITING

    Kaohsiung City, Taiwan

  • Kung Tien General Hospital

    RECRUITING

    Taichung, Taiwan

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, Taiwan

  • MacKay Memorial Hospital

    RECRUITING

    Taipei, Taiwan

  • Mt. Olympus Medical Research

    RECRUITING

    Houston, Texas, 77095, United States

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

  • New Horizons Research

    RECRUITING

    Palmetto Bay, Florida, 33176, United States

  • Reliant Medical Research

    RECRUITING

    Miami, Florida, 33165, United States

  • Salem Veterans Affairs Medical Center VAMC

    RECRUITING

    Salem, Virginia, 24153-6404, United States

  • Shin Kong Wu Ho Su Memorial Hospital

    RECRUITING

    Taipei, Taiwan

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, Taiwan

  • The Jackson Clinic PA

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Tri-Service General Hospital

    RECRUITING

    Taipei, Taiwan

  • Wasatch Clinical Research

    RECRUITING

    Salt Lake City, Utah, 84107, United States

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