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

NCT05930210 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ENERGI-F703 GEL

Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.

DRUG

ENERGI-F703 matched vehicle

Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.

Sponsors & Collaborators

  • Energenesis Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2025-12-30
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05930210 on ClinicalTrials.gov