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

Inclusion Criteria:

1. Subject must be at least 18 years old.

2. Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DMmedication 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 beforescreening.

3. Subject must have at least 1 cutaneous ulcer on the foot and not healing for atleast 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 durationwill be selected.

4. The target ulcer is classified as Grade 1 to Grade 2 ulcer according to WagnerGrading 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 or commit to the use of a reliable methodof birth control (must agree to use double-barrier contraception in the event ofsexual 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 andnegative urine pregnancy test within 24 hours before randomization (test notrequired for females of non-childbearing potential, defined as surgicallysterile [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 methodof contraception for the duration of the study and at least 30 days after studytreatment administration.

Exclusion Criteria:

1. History or evidence of osteomyelitis as confirmed by the investigator. Anx-ray/pathology assessment of debridement or a probe-to-bone (PTB) test will be usedto determine presence of osteomyelitis. However, participants who have a history orevidence of osteomyelitis in other parts of their body are eligible to participatein the study. If the medical history of osteomyelitis was cured by antibiotictherapy, surgery or amputation for more than 1 year, and no recurrence, no findingto 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 standardof care-only period between screening and randomization

3. Subjects with highly exudated wounds which require dressing changes more than 3times a day may be enrolled, but heavily exudated wounds should not be selected astarget ulcers

4. With poor nutritional status (serum albumin <2g/dL or prealbumin <10 mg/dL), poordiabetic control (hemoglobin A1c >12%), a leukocyte counts <2,000/mm3, abnormalliver function (aspartate aminotransferase, alanine aminotransferase >3 x upperlimit of normal range) within 21 days before Randomization visit

5. Requiring treatment with systemic corticosteroids, immunosuppressive orchemotherapeutic agents

6. With known or suspected hypersensitivity to any ingredients of study product andvehicle

7. With coronary heart disease with myocardial infarction, coronary artery bypassgraft, or percutaneous transluminal coronary angioplasty within 3 months prior tostudy (patients who have undergone peripheral angioplasty should be excluded unlessthe 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 1oz. spirits) within 6 months prior to screening (within 6 months prior to screeningincludes 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 orsquamous 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 thisstudy

13. With any condition judged by the investigator that entering the trial may bedetrimental to the subject -