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

NCT04078555 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ENERGI-F703-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  Day -21 to Day 99

• The accumulated confirmed target ulcer closure incidence at each of the post-treatment visit

  Day -21 to Day 85

• Incidence of vital signs abnormalities

  Day -21 to Day 169

• Incidence of physical examination abnormalities

  Day -21 to Day 169

Study Arms (2)

ENERGI-F703 GEL

EXPERIMENTAL

topical application on target venous leg ulcer, twice daily

Drug: ENERGI-F703 GEL

ENERGI-F703 GEL matched vehicle

PLACEBO COMPARATOR

topical application on target venous leg ulcer, twice daily

Drug: ENERGI-F703 GEL matched vehicle

Interventions

ENERGI-F703 GEL DRUG

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.

ENERGI-F703 GEL

ENERGI-F703 GEL matched vehicle DRUG

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.

ENERGI-F703 GEL matched vehicle

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With either gender aged at least 20 years old
• With venous reflux \>0.1 sec measured by duplex ultrasound imaging dated within 6 months prior to the Screening visit
• 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
• With the target ulcer size of 2 cm2 to 50 cm2
• Target VLU involves a full thickness skin loss, but without exposure of tendon, muscle, or bone
• Target VLU should be free of any necrosis or infection in any soft tissue and bone tissue
• Able to tolerate compression therapy
• Subject has signed the written informed consent form

You may not qualify if:

• Target VLU With active cellulitis or osteomyelitis
• With target ulcer size decreased by at least 30% after 2 weeks of standard care
• 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
• Requiring treatment with chemotherapeutic agents
• With known or suspected hypersensitivity to any ingredients of IP and matched vehicle
• 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
• (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)
• (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)
• With ankle brachial index (ABI) \< 0.6

Sponsors & Collaborators

• Energenesis Biomedical Co., Ltd.: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yifang Cheng, PhD

CONTACT

+886-2-2627-0835; yf@energenesis-biomedical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: July 26, 2022
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TW (1)