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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 2, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 30, 2025 to Dec 30, 2025
    • Study completion date: Dec 31, 2025 to Mar 31, 2026
    v6
  2. Primary completion date: Jul 31, 2024 to Sep 30, 2025
    • Study sites: 21 to 24
    • Study completion date: Dec 1, 2024 to Dec 31, 2025
    • Eligibility criteria shortened, about 4 words
    v5
  3. Study sites: 1 to 21v4
  4. Site contact updatedv3
  5. Study title shortened, about 8 wordsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05930210
Lead Sponsor Energenesis Biomedical Co., Ltd.
Conditions
(from sponsor)		 Diabetic Foot Ulcer, Foot Ulcer, Diabetes Mellitus, Wound
Related terms Diabetes Mellitus, Diabetic Foot, Foot Ulcer, Wounds and Injuries
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov