A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
Sponsored by Energenesis Biomedical Co., Ltd.
About this study
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.
Enrolling at this location
Mt. Olympus Medical Research
Houston, Texas
I'm interestedThis study also enrolls at 9 other locations. See all.
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Trial data sourced from ClinicalTrials.gov.