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

Exclusion Criteria

• •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. 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
• •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 (patients who have undergone peripheral angioplasty should be excluded unless the surgery was performed at least 30 days prior to screening)
• •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 (within 6 months prior to screening includes both drug abuse and alcohol abuse)
• •9. History or positive test results for HIV
• •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 -