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

Part of paid clinical trials in Miami, Florida.

Sponsor
Energenesis Biomedical Co., Ltd.
Study ID
NCT05930210
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ENERGI-F703 GEL — DRUG
    Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
  • ENERGI-F703 matched vehicle — DRUG
    Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.

Study Details

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.

Key Dates

Start date
May 30, 2023
Status verified
Mar 2025
Primary completion
Dec 30, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ENERGI-F703 GEL
    ENERGI-F703, topical application, 2 times daily for 16 weeks
  • Placebo Comparator: ENERGI-F703 matched vehicle
    ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks

Primary Outcome Measure

The ulcer complete closure rate [ Time Frame: Weeks 16 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
A and D Doctor CenterMiamiFlorida33135
Yordan Orive, Dr.
Advanced Medical Research InstituteMiamiFlorida33174-3201
Enrique Pelayo, Dr.
Bioclinical ResearchMiamiFlorida33155
Rogelio Iglesias, Dr.
Reliant Medical ResearchMiamiFlorida33165
Ramses Vega, Dr.
New Horizons ResearchPalmetto BayFlorida33176
Derrick H. Diaz, Dr.
IACT HealthColumbusGeorgia31904
Joseph Surber, Dr.
The Jackson Clinic PAJacksonTennessee38305
Kellie Wallace-Wilding, Dr.
Mt. Olympus Medical ResearchHoustonTexas77095
Julie Lester, Dr.
Wasatch Clinical ResearchSalt Lake CityUtah84107
Clark Larsen, Dr.
Salem Veterans Affairs Medical Center VAMCSalemVirginia24153-6404
Aliza Lee, Dr.

Find similar trials in Miami, FL

By research site
A and D Doctor Center· Miami, FLAdvanced Medical Research Institute· Miami, FLBioclinical Research· Miami, FLReliant Medical Research· Miami, FLNew Horizons Research· Palmetto Bay, FLIACT Health· Columbus, GA

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