A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer

NCT05930210 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ENERGI-F703-04
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 24

Brief Summary

This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (\<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.

Conditions

Diabetic Foot Ulcer; Foot Ulcer; Diabetes Mellitus; Wound

Keywords

Diabetic Foot Ulcer; Diabetes Mellitus; Wound Healing

Outcome Measures

Primary Outcomes (1)

• The ulcer complete closure rate

  Proportion of subjects with a recording of complete ulcer closure at Week 16 (the end of the treatment period) as assessed by the investigator, where such closure is subsequently confirmed at 2 consecutive study visits over a 2-week period (ie, by Week 18). A complete ulcer closure is defined as 100% skin re epithelialization without drainage or dressing requirements.

  Weeks 16

Secondary Outcomes (3)

• The time to ulcer closure

  Weeks 4, 6, 8, 10, 12, 14, and 16

• The frequency and severity of adverse events

  Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28

• The proportion of subjects with complete ulcer closure

  Weeks 4, 6, 8, 10, 12, 14, and 16

Study Arms (2)

ENERGI-F703 GEL

EXPERIMENTAL

ENERGI-F703, topical application, 2 times daily for 16 weeks

Drug: ENERGI-F703 GEL

ENERGI-F703 matched vehicle

PLACEBO COMPARATOR

ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks

Drug: ENERGI-F703 matched vehicle

Interventions

ENERGI-F703 GEL DRUG

Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.

ENERGI-F703 GEL

ENERGI-F703 matched vehicle DRUG

Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.

ENERGI-F703 matched vehicle

Eligibility Criteria

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

You may qualify if:

• Subject must be at least 18 years old.
• Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DM medication treatment or subjects with naïve DM with duplicated hemoglobin A1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least 1 week apart before screening.
• Subject must have at least 1 cutaneous ulcer on the foot and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If 2 or more ulcers have the largest size, the one with worst grade will be selected. If 2 or more ulcers have the largest size and grade, the one with longest duration will be selected.
• The target ulcer is classified as Grade 1 to Grade 2 ulcer according to Wagner Grading System and with ulcer size of 1.5 cm2 to 25 cm2.
• Diabetic foot ulcers should be free of any necrosis or infection
• Subject has signed the written informed consent form
• Male subjects must be surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence for the duration of the study and for 30 days after study treatment administration.
• Female subjects are eligible only if all of the following apply:
• Not pregnant with a negative serum pregnancy test at Screening visit and negative urine pregnancy test within 24 hours before randomization (test not required for females of non-childbearing potential, defined as surgically sterile \[eg, hysterectomy or bilateral oophorectomy\] or postmenopausal \[amenorrheic for at least 1 year\])
• Not lactating
• Not planning to become pregnant during the study
• If of childbearing potential, commits to the use of a highly effective method of contraception for the duration of the study and at least 30 days after study treatment administration.

You may not qualify if:

• History or evidence of osteomyelitis as confirmed by the investigator. An x-ray/pathology assessment of debridement or a probe-to-bone (PTB) test will be used to determine presence of osteomyelitis. However, participants who have a history or evidence of osteomyelitis in other parts of their body are eligible to participate in the study. If the medical history of osteomyelitis was cured by antibiotic therapy, surgery or amputation for more than 1 year, and no recurrence, no finding to the current leg and foot after testing, the participant can be enrolled
• With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
• Subjects with highly exudated wounds which require dressing changes more than 3 times a day may be enrolled, but heavily exudated wounds should not be selected as target ulcers
• With poor nutritional status (serum albumin \<2g/dL or prealbumin \<10 mg/dL), poor diabetic control (hemoglobin A1c \>12%), a leukocyte counts \<2,000/mm3, abnormal liver function (aspartate aminotransferase, alanine aminotransferase \>3 x upper limit of normal range) within 21 days before Randomization visit
• Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
• With known or suspected hypersensitivity to any ingredients of study product and vehicle
• With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study (patients who have undergone peripheral angioplasty should be excluded unless the surgery was performed at least 30 days prior to screening)
• Known or suspected history of drug abuse or a recent history of alcohol abuse (regularly drinks \>4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 6 months prior to screening (within 6 months prior to screening includes both drug abuse and alcohol abuse)
• History or positive test results for HIV
• Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
• Ankle brachial index \<0.8 or \>1.4
• Enrollment in any investigational drug trial within 4 weeks before entering this study
• With any condition judged by the investigator that entering the trial may be detrimental to the subject -

Sponsors & Collaborators

• Energenesis Biomedical Co., Ltd.: lead

Study Sites (24)

A and D Doctor Center

Miami, Florida, 33135, United States

RECRUITING

Bioclinical Research

Miami, Florida, 33155, United States

RECRUITING

Reliant Medical Research

Miami, Florida, 33165, United States

RECRUITING

Advanced Medical Research Institute

Miami, Florida, 33174-3201, United States

RECRUITING

New Horizons Research

Palmetto Bay, Florida, 33176, United States

RECRUITING

IACT Health

Columbus, Georgia, 31904, United States

RECRUITING

The Jackson Clinic PA

Jackson, Tennessee, 38305, United States

RECRUITING

Mt. Olympus Medical Research

Houston, Texas, 77095, United States

RECRUITING

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

RECRUITING

Salem Veterans Affairs Medical Center VAMC

Salem, Virginia, 24153-6404, United States

RECRUITING

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, Taiwan

RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Kung Tien General Hospital

Taichung, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Cathay General Hospital

Taipei, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Shin Kong Wu Ho Su Memorial Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yifang Cheng, PhD

CONTACT

+886-2-26270835; ct@energenesis-biomedical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 5, 2023
• Study Start: May 30, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-03

Locations

US (10); TW (14)