A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ENERGI-F703 GEL ENERGI-F703, topical application, 2 times daily for 16 weeks |
Drug: ENERGI-F703 GEL
Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
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Placebo Comparator: ENERGI-F703 matched vehicle ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks |
Drug: ENERGI-F703 matched vehicle
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
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Outcome Measures
Primary Outcome Measures
- The ulcer complete closure rate [Weeks 16]
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.
Secondary Outcome Measures
- The time to ulcer closure [Weeks 4, 6, 8, 10, 12, 14, and 16]
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
- The frequency and severity of adverse events [Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28]
Frequency and severity of adverse events (AEs), including treatment emergent AEs, serious AEs, treatment-related AEs, and treatment-related serious AEs
- The proportion of subjects with complete ulcer closure [Weeks 4, 6, 8, 10, 12, 14, and 16]
Proportion of subjects with confirmed complete ulcer closure as assessed by the investigator.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject must be at least 18 years old.
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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.
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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.
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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.
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Diabetic foot ulcers should be free of any necrosis or infection
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Subject has signed the written informed consent form
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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.
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Female subjects are eligible only if all of the following apply:
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Not pregnant with a negative serum pregnancy test at Screening visit and negative urine pregnancy test within 24 hours before randomization (test not required for females of non-childbearing potential, defined as surgically sterile [eg, hysterectomy or bilateral oophorectomy] or postmenopausal [amenorrheic for at least 1 year])
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Not lactating
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Not planning to become pregnant during the study
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If of childbearing potential, commits to the use of a highly effective method of contraception for the duration of the study and at least 30 days after study treatment administration.
Exclusion Criteria:
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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.
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With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
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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
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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
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Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
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With known or suspected hypersensitivity to any ingredients of study product and vehicle
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With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study
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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
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History or positive test results for HIV, presence of active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV)
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Hepatitis B surface antigen positive at screening is exclusionary
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Subjects with history of past or resolved HBV infection or hepatitis B core antibody positive at screening are eligible if HBV DNA viral load ≤2000 IU/mL in the absence of antiviral therapy and during the previous 12 weeks prior to the viral load evaluation with normal transaminases values
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Subjects with a history of HCV infection or HCV antibody positive at screening are eligible if HCV viral load is below the level of detection
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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
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Ankle brachial index <0.8 or >1.4
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Enrollment in any investigational drug trial within 4 weeks before entering this study
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With any condition judged by the investigator that entering the trial may be detrimental to the subject -
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Bioclinical Research | Miami | Florida | United States | 33155 |
Sponsors and Collaborators
- Energenesis Biomedical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ENERGI-F703-04