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

Recruiting Phase 3 Interventional Study
Diabetic Foot Ulcer Foot Ulcer Diabetes Mellitus Wound
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
Energenesis Biomedical Co., Ltd. · Industry
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About This Trial
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 GE…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject must be at least 18 years old. 2. Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DM medication treatment or subjects with naïve DM with duplicated hemoglobin A1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least 1 week…
Contacts

Yifang Cheng, PhD

+886-2-26270835

ct@energenesis-biomedical.com

CONTACT