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

NCT ID: NCT04078555

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2025-06-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ENERGI-F703 GEL

topical application on target venous leg ulcer, twice daily

Group Type: EXPERIMENTAL

ENERGI-F703 GEL

Intervention Type: 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

topical application on target venous leg ulcer, twice daily

Group Type: PLACEBO_COMPARATOR

ENERGI-F703 GEL matched vehicle

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Energenesis Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yifang Cheng, PhD

Role: CONTACT

yf@energenesis-biomedical.com

+886-2-2627-0835 ext. 701

Facility Contacts

Cha-Chun Chen, MD

Role: primary

Other Identifiers

ENERGI-F703-02

Identifier Type: -

Identifier Source: org_study_id