Condition: Diabetic Foot Ulcer · Foot Ulcer · Diabetes Mellitus · Sponsor: Energenesis Biomedical Co., Ltd.
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.
This description comes directly from the study's public registry record.
Yifang Cheng, PhD · +886-2-26270835 · ct@energenesis-biomedical.com
Always discuss trial participation with your own doctor first.
| A and D Doctor Center | Miami, Florida, United States | Recruiting |
| Bioclinical Research | Miami, Florida, United States | Recruiting |
| Reliant Medical Research | Miami, Florida, United States | Recruiting |
| Advanced Medical Research Institute | Miami, Florida, United States | Recruiting |
| New Horizons Research | Palmetto Bay, Florida, United States | Recruiting |
| IACT Health | Columbus, Georgia, United States | Recruiting |
| The Jackson Clinic PA | Jackson, Tennessee, United States | Recruiting |
| Mt. Olympus Medical Research | Houston, Texas, United States | Recruiting |
| Wasatch Clinical Research | Salt Lake City, Utah, United States | Recruiting |
| Salem Veterans Affairs Medical Center VAMC | Salem, Virginia, United States | Recruiting |
| Ditmanson Medical Foundation Chia-Yi Christian Hospital | Chiayi City, Taiwan | Recruiting |
| Kaohsiung Medical University Hospital | Kaohsiung City, Taiwan | Recruiting |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05930210