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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
230
Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
A and D Doctor Center
Miami, Florida, United States
RECRUITINGBioclinical Research
Miami, Florida, United States
RECRUITINGReliant Medical Research
Miami, Florida, United States
RECRUITINGAdvanced Medical Research Institute
Miami, Florida, United States
RECRUITINGNew Horizons Research
Palmetto Bay, Florida, United States
RECRUITINGIACT Health
Columbus, Georgia, United States
RECRUITINGThe Jackson Clinic PA
Jackson, Tennessee, United States
RECRUITINGMt. Olympus Medical Research
Houston, Texas, United States
RECRUITINGWasatch Clinical Research
Salt Lake City, Utah, United States
RECRUITINGSalem Veterans Affairs Medical Center VAMC
Salem, Virginia, United States
RECRUITING...and 14 more locations
The ulcer complete closure rate
Proportion of subjects with a recording of complete ulcer closure at Week 16 (the end of the treatment period) as assessed by the investigator, where such closure is subsequently confirmed at 2 consecutive study visits over a 2-week period (ie, by Week 18). A complete ulcer closure is defined as 100% skin re epithelialization without drainage or dressing requirements.
Time frame: Weeks 16
The time to ulcer closure
Time to ulcer closure in weeks, defined as the time from randomization to first record of complete closure, as assessed by the investigator, where complete closure is subsequently confirmed at 2 consecutive study visits over a 2-week period
Time frame: Weeks 4, 6, 8, 10, 12, 14, and 16
The frequency and severity of adverse events
Frequency and severity of adverse events (AEs), including treatment emergent AEs, serious AEs, treatment-related AEs, and treatment-related serious AEs
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28
The proportion of subjects with complete ulcer closure
Proportion of subjects with confirmed complete ulcer closure as assessed by the investigator.
Time frame: Weeks 4, 6, 8, 10, 12, 14, and 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.