Evaluating ENERGI-F703 GEL for treating venous leg ulcers

A Randomized, Double-Blind, Placebo-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Venous Leg Ulcer (VLU)

This study is testing a new gel to see if it helps heal stubborn venous leg ulcers in adults who have had them for at least four weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years to 85 Years
• Sex: All
• Sponsor: Energenesis Biomedical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT04078555 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ENERGI-F703 GEL in patients aged 20 and older with venous leg ulcers. Participants will be recruited from multiple sites in Taiwan and will undergo a treatment period of 84 days, followed by an additional 84-day follow-up. The study aims to determine how well the gel promotes healing in venous ulcers that have not healed for at least four weeks.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 20 and older with venous leg ulcers that have not healed for at least four weeks.

Not a fit: Patients with active infections or those whose ulcers have shown significant improvement with standard care may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients suffering from venous leg ulcers.

How similar studies have performed: While this approach is being tested in this specific formulation, similar studies have shown promise in treating venous leg ulcers with other topical treatments.

Eligibility criteria

Inclusion Criteria:

1. With either gender aged at least 20 years old
2. With venous reflux \>0.1 sec measured by duplex ultrasound imaging dated within 6 months prior to the Screening visit
3. With at least one venous ulcer on the lower leg (knee to ankle inclusive) and not healing for at least 4 weeks. The ulcer with the largest surface area will be selected as target ulcer. If two or more ulcers have the largest size, the one with the longest duration will be selected
4. With the target ulcer size of 2 cm2 to 50 cm2
5. Target VLU involves a full thickness skin loss, but without exposure of tendon, muscle, or bone
6. Target VLU should be free of any necrosis or infection in any soft tissue and bone tissue
7. Able to tolerate compression therapy
8. Subject has signed the written informed consent form

Exclusion Criteria:

1. Target VLU With active cellulitis or osteomyelitis
2. With target ulcer size decreased by at least 30% after 2 weeks of standard care
3. With poor nutritional status (albumin \< 2g/dl), poor diabetic control (HbA1c \> 12%), a leukocyte counts \< 2,000/mm3, abnormal liver function (AST, ALT\>3 × upper limit of normal range) tests within 14 days prior to Screening visit or 28 days prior to Randomization visit
4. Requiring treatment with chemotherapeutic agents
5. With known or suspected hypersensitivity to any ingredients of IP and matched vehicle
6. With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to Screening visit
7. (1) Female subject of childbearing potential who:

   * is lactating; or
   * has positive pregnancy test result at eligibility checking; or
   * refuses to adopt at least one form of birth control from signing informed consent to the end of study

   Note:

   Acceptable forms include:

   Established use of oral, injected or implanted hormonal methods of contraception. Placement of an intrauterine device (IUD) or intrauterine system (IUS).Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)

   7(2) Male subject with female spouse/partners who are of childbearing potential refuses to adopt at least one form of birth control (at least one of which must be a barrier method) from signing informed consent to the end of study)
8. With ankle brachial index (ABI) \< 0.6
9. Enrollment in any investigational drug trial within 4 weeks before entering this study
10. With any condition judged by the investigator that entering the trial may be detrimental to the subject

Where this trial is running

Taipei

• Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Yifang Cheng, PhD

Conditions Venous Leg Ulcer