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

Evaluating ENERGI-F703 Gel for diabetic foot ulcers in a study.

Recruiting
18 years and older
All
Phase 3

This study tests a new gel called **ENERGI-F703** to help heal diabetic foot ulcers, which are open sores on feet of people with diabetes. The study is **Phase 3**, meaning it's one of the last steps before the gel could be approved for general use. People with ulcers graded as **Wagner Grade 1 or 2** (mild to moderate severity) can join. They will be split into two groups: one gets the gel, and the other gets a non-active gel, with neither knowing which they receive.

The study lasts up to **31 weeks**: 2-3 weeks for initial checks, 16 weeks for treatment, and 12 weeks for follow-up. Participants must be at least 18, have diabetes, and have a foot ulcer that hasn't healed in at least 4 weeks. The ulcer should not be infected or have dead tissue.

  • Participants need to visit the clinic multiple times over the 31 weeks.
  • Participants will be randomly assigned to a group and won't know which treatment they receive.
  • Participants must agree to use birth control if they are of childbearing potential.
Study details
    Diabetic Foot Ulcer
    Foot Ulcer
    Diabetes Mellitus
    Wound

NCT05930210

Energenesis Biomedical Co., Ltd.

22 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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