A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer

Last updated: February 16, 2024
Sponsor: Energenesis Biomedical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Venous Leg Ulcers

Stasis Dermatitis

Ulcers

Treatment

ENERGI-F703 GEL

ENERGI-F703 GEL matched vehicle

Clinical Study ID

NCT04078555
ENERGI-F703-02
  • Ages 20-85
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU). Subjects will be recruited from multiple sites in Taiwan. The treatment period will be 84 days with another 84-day follow-up period.

Eligibility Criteria

Inclusion

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 6months prior to the Screening visit
  3. With at least one venous ulcer on the lower leg (knee to ankle inclusive) and nothealing for at least 4 weeks. The ulcer with the largest surface area will be selectedas target ulcer. If two or more ulcers have the largest size, the one with the longestduration 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 bonetissue
  7. Able to tolerate compression therapy
  8. Subject has signed the written informed consent form

Exclusion

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%), aleukocyte counts < 2,000/mm3, abnormal liver function (AST, ALT>3 × upper limit ofnormal range) tests within 14 days prior to Screening visit or 28 days prior toRandomization 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 priorto 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 consentto 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 methodsof contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) 7(2) Male subject with female spouse/partners who are of childbearing potentialrefuses to adopt at least one form of birth control (at least one of which must be abarrier method) from signing informed consent to the end of study)
  1. With ankle brachial index (ABI) < 0.6
  2. Enrollment in any investigational drug trial within 4 weeks before entering this study
  3. With any condition judged by the investigator that entering the trial may bedetrimental to the subject

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: ENERGI-F703 GEL
Phase: 2
Study Start date:
July 26, 2022
Estimated Completion Date:
June 15, 2025

Connect with a study center

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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