Wasatch Clinical Research | Salt Lake City, UT
Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
Diabetic foot ulcers should be free of any necrosis or infection
Subject has signed the written informed consent form
Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence for the duration of the study and for 30 days after study treatment administration.
Female subjects are eligible only if all of the following apply:
Exclusion criteria
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.
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
Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
With known or suspected hypersensitivity to any ingredients of study product and vehicle
With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study
Known or suspected history of drug abuse or a recent history of alcohol abuse (regularly drinks >4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 6 months prior to screening
History or positive test results for HIV, presence of active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV)
Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
Ankle brachial index <0.8 or >1.4
Enrollment in any investigational drug trial within 4 weeks before entering this study
With any condition judged by the investigator that entering the trial may be detrimental to the subject -
Primary purpose
Allocation
Interventional model
Masking
230 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Yifang Cheng, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal