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A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
Led by Energenesis Biomedical Co., Ltd. · Updated on 2025-10-02
230
Participants Needed
24
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with diabetes mellitus, either currently on diabetes medication or confirmed by blood tests with hemoglobin A1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least 1 week apart before screening
- Have at least one foot ulcer that has not healed for at least 4 weeks
- Target ulcer classified as Wagner Grade 1 or Grade 2 with size between 1.5 cm² and 25 cm²
- Ulcers must be free of necrosis or infection
- Signed written informed consent form
- Male participants must be surgically sterile or agree to reliable birth control methods during the study and 30 days after
- Female participants must not be pregnant or lactating, have negative pregnancy tests, and agree to use effective contraception if of childbearing potential during the study and 30 days after
You will not qualify if you...
- History or evidence of osteomyelitis in the target ulcer area
- Target ulcer size decreased by at least 30% after 2 weeks of standard care alone between screening and randomization
- Target ulcer is heavily exudating requiring dressing changes more than 3 times a day
- Poor nutritional status (serum albumin <2 g/dL or prealbumin <10 mg/dL), poor diabetic control (hemoglobin A1c >12%), low leukocyte counts (<2,000/mm³), or abnormal liver function within 21 days before randomization
- Current treatment with systemic corticosteroids, immunosuppressive, or chemotherapy agents
- Known or suspected allergy to study product or vehicle ingredients
- Recent coronary heart disease events within 3 months prior to study
- History of drug or alcohol abuse within 6 months prior to screening
- History or positive test for HIV
- Cancer diagnosis in the last 2 years except certain skin and cervical cancers
- Abnormal ankle brachial index (<0.8 or >1.4)
- Participation in another investigational drug trial within 4 weeks before this study
- Any condition judged by the investigator to make participation unsafe or detrimental
AI-Screening
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Trial Site Locations
Total: 24 locations
1
A and D Doctor Center
Miami, Florida, United States, 33135
Actively Recruiting
2
Bioclinical Research
Miami, Florida, United States, 33155
Actively Recruiting
3
Reliant Medical Research
Miami, Florida, United States, 33165
Actively Recruiting
4
Advanced Medical Research Institute
Miami, Florida, United States, 33174-3201
Actively Recruiting
5
New Horizons Research
Palmetto Bay, Florida, United States, 33176
Actively Recruiting
6
IACT Health
Columbus, Georgia, United States, 31904
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7
The Jackson Clinic PA
Jackson, Tennessee, United States, 38305
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8
Mt. Olympus Medical Research
Houston, Texas, United States, 77095
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9
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
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10
Salem Veterans Affairs Medical Center VAMC
Salem, Virginia, United States, 24153-6404
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11
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan
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12
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
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13
China Medical University Hospital
Taichung, Taiwan
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14
Kung Tien General Hospital
Taichung, Taiwan
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15
Taichung Veterans General Hospital
Taichung, Taiwan
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16
Chi Mei Medical Center
Tainan, Taiwan
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17
National Cheng Kung University Hospital
Tainan, Taiwan
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18
Cathay General Hospital
Taipei, Taiwan
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19
MacKay Memorial Hospital
Taipei, Taiwan
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20
National Taiwan University Hospital
Taipei, Taiwan
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21
Shin Kong Wu Ho Su Memorial Hospital
Taipei, Taiwan
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22
Taipei Veterans General Hospital
Taipei, Taiwan
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23
Tri-Service General Hospital
Taipei, Taiwan
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24
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Actively Recruiting
Research Team
Y
Yifang Cheng, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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