Back to search results

ENERGI-F703 GEL for Diabetic Foot Ulcers

This study is testing a gel called ENERGI-F703 GEL to see if it helps heal diabetic foot ulcers. Researchers want to compare it to a "vehicle control," which is a gel that looks the same but doesn't contain the active ingredient. You might be able to join if you are at least 18 years old, have been diagnosed with diabetes, and have a diabetic foot ulcer (Wagner Grade 1 or 2). The main goal is to see how many ulcers completely close after 16 weeks of treatment. This study plans to enroll 230 people, but its current recruitment status is unclear.

Study design
This is a Phase 3, randomized, double-blind study involving multiple centers. About 230 participants will be randomly assigned to receive either ENERGI-F703 GEL or the vehicle control.
What's involved
The total study duration will be up to 31 weeks, including a screening period of 2-3 weeks, 16 weeks of treatment/observation, and a 12-week safety follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 12 weeks after their last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05930210

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Energenesis Biomedical Co., Ltd.
~230 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:ENERGI-F703 GELENERGI-F703 matched vehicle

At a glance

Recruiting sites
24 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The ulcer complete closure rate
Measured over Weeks 16

Conditions

Diabetic Foot Ulcer
Foot Ulcer
Diabetes Mellitus
Wound

Explore related trials

Diabetic foot ulcer

Where it's being run

24 sites across 7 states
Taiwan14
Florida5
Georgia1
Tennessee1
Texas1
Utah1
Virginia1

Who to contact

Yifang Cheng, PhD
[email protected]
+886-2-26270835
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

What this trial measures

  • The ulcer complete closure rateWeeks 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.