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

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

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.

Condition or disease
Intervention/treatment
Phase

Diabetic Foot Ulcer Foot Ulcer Diabetes Mellitus Wound
Drug: ENERGI-F703 GEL Drug: ENERGI-F703 matched vehicle
Phase 3

Source: View full study details on ClinicalTrials.gov

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July 8, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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