A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnergenesis Biomedical Co., Ltd.
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be at least 18 years old.
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 apart before screening.
Subject must have at least 1 cutaneous ulcer on the foot and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If 2 or more ulcers have the largest size, the one with worst grade will be selected. If 2 or more ulcers have the largest size and grade, the one with longest duration will be selected.
The target ulcer is classified as Grade 1 to Grade 2 ulcer according to Wagner Grading System and with ulcer size of 1.5 cm2 to 25 cm2.
Disqualifiers
History or evidence of osteomyelitis as confirmed by the investigator. An x-ray/pathology assessment of debridement or a probe-to-bone (PTB) test will be used to determine presence of osteomyelitis. However, participants who have a history or evidence of osteomyelitis in other parts of their body are eligible to participate in the study. If the medical history of osteomyelitis was cured by antibiotic therapy, surgery or amputation for more than 1 year, and no recurrence, no finding to the current leg and foot after testing, the participant can be enrolled
With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
Subjects with highly exudated wounds which require dressing changes more than 3 times a day may be enrolled, but heavily exudated wounds should not be selected as target ulcers
With poor nutritional status (serum albumin <2g/dL or prealbumin <10 mg/dL), poor diabetic control (hemoglobin A1c >12%), a leukocyte counts <2,000/mm3, abnormal liver function (aspartate aminotransferase, alanine aminotransferase >3 x upper limit of normal range) within 21 days before Randomization visit
Trial design
Design model
Parallel
Treatments tested in this trial
ENERGI-F703 GEL
DrugStandard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
ENERGI-F703 matched vehicle
DrugStandard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: ENERGI-F703 GELExperimental treatment 1 intervention
Group B: ENERGI-F703 matched vehiclePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 16Secondary outcomes
1
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 162
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 283
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 16Sponsors and contacts
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Source ClinicalTrials.gov