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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Drug: ENERGI-F703 GEL; Drug: ENERGI-F703 GEL matched vehicle

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yifang Cheng, PhD; Phone Number: 701 +886-2-2627-0835; Email: yf@energenesis-biomedical.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Shin Kong Wu Ho-Su Memorial Hospital
    • Contact: Cha-Chun Chen, MD
    • Principal Investigator: Cha-Chun Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENERGI-F703 GEL; topical application on target venous leg ulcer, twice daily	Drug: ENERGI-F703 GEL; The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first. The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size.
Placebo Comparator: ENERGI-F703 GEL matched vehicle; topical application on target venous leg ulcer, twice daily	Drug: ENERGI-F703 GEL matched vehicle; The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first. The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complete ulcer closure	Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.	Day -21 to Day 99

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in target ulcer area from baseline to each post-treatment visit		Day -21 to Day 85
Time-to-Complete ulcer closure of target ulcer	Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.	Day -21 to Day 99
The accumulated confirmed target ulcer closure incidence at each of the post-treatment visit	Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.	Day -21 to Day 85
Incidence of vital signs abnormalities	Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.	Day -21 to Day 169
Incidence of physical examination abnormalities	Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others.	Day -21 to Day 169
Incidence of laboratory examination results abnormalities	The laboratory examinations include Hematology tests (CBC), Biochemistry (AST, ALP, ALT, serum creatinine, BUN, albumin and fasting glucose) and Urinalysis (pH, glucose, RBC, WBC and protein).	Day -21 to Day 169
Incidence of AEs and SAEs		Day -21 to Day 169

Collaborators and Investigators

• Sponsor: Energenesis Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 1, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: ENERGI-F703-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No