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

Eligibility Criteria

• 1. Subject must be at least 18 years old.
• 2. 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.
• 3. 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.
• 4. 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.
• 5. Diabetic foot ulcers should be free of any necrosis or infection
• 6. Subject has signed the written informed consent form
• 7. 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.
• 8. Female subjects are eligible only if all of the following apply:
• * 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 \[amenorrheic for at least 1 year\])
• * Not lactating
• * Not planning to become pregnant during the study
• * 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.
• 1. 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.
• 2. With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
• 3. 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
• 4. 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
• 5. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
• 6. With known or suspected hypersensitivity to any ingredients of study product and vehicle
• 7. With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study
• 8. 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
• 9. History or positive test results for HIV, presence of active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV)
• 1. Hepatitis B surface antigen positive at screening is exclusionary
• 2. 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
• 3. 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
• 10. 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
• 11. Ankle brachial index \<0.8 or \>1.4
• 12. Enrollment in any investigational drug trial within 4 weeks before entering this study
• 13. With any condition judged by the investigator that entering the trial may be detrimental to the subject -