A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
NCT ID: NCT05930210
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
230 participants
INTERVENTIONAL
2023-05-30
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ENERGI-F703 GEL
ENERGI-F703, topical application, 2 times daily for 16 weeks
ENERGI-F703 GEL
Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
ENERGI-F703 matched vehicle
ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks
ENERGI-F703 matched vehicle
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
Interventions
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ENERGI-F703 GEL
Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
ENERGI-F703 matched vehicle
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. 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.
5. Diabetic foot ulcers should be free of any necrosis or infection
6. Subject has signed the written informed consent form
7. 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.
8. 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.
Exclusion Criteria
2. With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
3. 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
4. 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
5. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
6. With known or suspected hypersensitivity to any ingredients of study product and vehicle
7. 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)
8. 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)
9. History or positive test results for HIV
10. 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
11. Ankle brachial index \<0.8 or \>1.4
12. Enrollment in any investigational drug trial within 4 weeks before entering this study
13. With any condition judged by the investigator that entering the trial may be detrimental to the subject -
18 Years
ALL
No
Sponsors
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Energenesis Biomedical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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A and D Doctor Center
Miami, Florida, United States
Bioclinical Research
Miami, Florida, United States
Reliant Medical Research
Miami, Florida, United States
Advanced Medical Research Institute
Miami, Florida, United States
New Horizons Research
Palmetto Bay, Florida, United States
IACT Health
Columbus, Georgia, United States
The Jackson Clinic PA
Jackson, Tennessee, United States
Mt. Olympus Medical Research
Houston, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Salem Veterans Affairs Medical Center VAMC
Salem, Virginia, United States
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Kung Tien General Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
MacKay Memorial Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Shin Kong Wu Ho Su Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Yordan Orive, Dr.
Role: primary
Rogelio Iglesias, Dr.
Role: primary
Ramses Vega, Dr.
Role: primary
Enrique Pelayo, Dr.
Role: primary
Derrick H. Diaz, Dr.
Role: primary
Joseph Surber, Dr.
Role: primary
Kellie Wallace-Wilding, Dr.
Role: primary
Julie Lester, Dr.
Role: primary
Clark Larsen, Dr.
Role: primary
Aliza Lee, Dr.
Role: primary
Chien-Liang Fang, Dr.
Role: primary
Shu-Hung Huang, Dr.
Role: primary
Hsin-Han Chen, Dr.
Role: primary
Shih-Ting Tseng, Dr.
Role: primary
Yiling Lin, Dr.
Role: primary
Chun Chia Chen, Dr.
Role: primary
Shin-Chen Pan, Dr.
Role: primary
Chi-Ming Pu, Dr.
Role: primary
Ming Feng Tsai, Dr.
Role: primary
Hui-Fu Huang, Dr.
Role: primary
Cha-Chun Chen, Dr.
Role: primary
Chih-Hsun Lin, Dr.
Role: primary
Hao-Yu Chiao, Dr.
Role: primary
Jiun-Ting Yeh, Dr.
Role: primary
Other Identifiers
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ENERGI-F703-04
Identifier Type: -
Identifier Source: org_study_id
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