Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

Inclusion Criteria:

1. Subjects, male or female, aged 18 to 80 years (inclusive) with Type 1 or Type 2diabetes undergoing therapy for glycemic control using available diabetes drugsincluding insulin.

2. Subject has a glycosylated hemoglobin, HbA1c ≦ 12%.

3. Presence of at least one diabetic foot ulcer that meets all of the followingcriteria:

4. A full-thickness ulcer of UTWCS Grade I-A or II-A

5. Ulcer size (area) is > 1 cm2 and ≤ 20 cm2 (post-debridement at time ofscreening and randomization)

6. Ulcer is located on or below the malleoli and presents duration of between 6weeks and 12 months (at time of screening).

7. There is a minimum 3 cm margin between the qualifying Target Ulcer and anyother ulcers on the specified foot (post-debridement)

8. No active infection by clinical inspection as defined by IDSA/IWGDF criteriaNote: If the subject has more than one qualifying diabetic foot ulcer, the mostsevere ulcer will be designated as the target ulcer.

9. Subject has adequate vascular perfusion of the affected limb, confirmed byAnkle-Brachial Index (ABI) > 0.8 and < 1.3, and transcutaneous pressure of oxygen (TcPO2) > 30 mmHg on at least one lead.

10. Subject, if female of child-bearing potential, has a negative serum pregnancy testat screening, must not be breastfeeding, and willing to use 2 medically acceptedmethods of contraception (e.g., barrier contraceptives [female condom, or diaphragmwith a spermicidal gel], hormonal contraceptives [implants, injectables, combinationoral contraceptives, transdermal patches, or contraceptive rings], and intrauterinedevices) during the study (excluding women who are not of childbearing potentialand/or who have been sterilized).

11. Subject should be able to walk and stand on the non-target ulcer limb.

12. Subject is willing to use an off-loading device for the target ulcer on the plantarwhile ambulation for the duration of the study.

13. Subject / identified caregiver trained on the study procedures is able and willingto comply with study procedures.

14. A signed and dated informed consent form has been obtained from the subject prior toany study-related procedures being performed.

Exclusion Criteria:

1. In response to standard of care, ulcer size reduction is > 30% during the two-weekrun-in Screening Period (between the first Screening Visit/V0 and Baseline/V2).

2. Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitisshould be ruled out by clinical examination (probing of the wound) and X-rayfindings.

3. Presence of necrosis, purulence or sinus tracts that cannot be removed bydebridement.

4. Body mass index (BMI) > 42 kg/m2

5. Laboratory values at Screening of:

6. White Blood Cells (WBC) < 3.0 X 109 cells/L；> 12.0 X 109 cells/L

7. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) andalanine transaminase (ALT)] > 3x the upper limit of normal

8. Albumin < 2.5 g/dL

9. Renal function studies [Serum Creatinine and Urea] > 3x the upper limit ofnormal

10. Presence of any clinically significant medical condition(s) in medical historyduring screening period that, in the opinion of the investigator, could interferewith wound healing, including but not limited to the following:

11. Acute or unstable Charcot foot

12. Current sepsis

13. Active malignant disease. A subject, who has had a malignant disease in thepast, was treated and is currently disease-free, may be considered for studyentry.

14. Acquired immune deficiency syndrome (AIDS) or HIV positive.

15. Subject is currently receiving (i.e., within 30 days of randomization visit) orscheduled to receive any of following medication or therapies, could interfere withwound healing during the study.

16. immunosuppressants (including chronic systemic corticosteroids)

17. cytotoxic chemotherapy

18. cytostatic therapy

19. autoimmune disease therapy

20. dialysis

21. lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery)

22. growth factors

23. hyperbaric oxygen therapy

24. bioengineered tissue or skin substitutes

25. application of topical steroids to the ulcer

26. use of any investigational drug(s)

27. Subjects whose non-target ulcer limb is disabled or amputated above the ankle.

28. Subject's target ulcer is located on the plantar foot with all toes amputated.

29. Subjects who need to stand continuously for more than 4 hours / day and havedifficulty complying with off-loading instruction.

30. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol ordrug abuse, determined from the subject's medical history, which, in the opinion ofthe Investigator, may pose a threat to subject compliance.

31. Has any other factor which may, in the opinion of the investigator, compromiseparticipation and/or follow-up in the study.