Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

• Has signed a written informed consent prior to the first study evaluation;

• Male or female is at least 20 and \< 80 years of age;

• Diabetes mellitus (type 1 or 2) with an HbA1c \< 12.0% measured during screening or within three months prior to randomization;

• An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;

• The target ulcer must have the following characteristics:

‣ Grade 1 or 2 per Wagner Ulcer Classification System;

⁃ No higher than the ankle;

⁃ No active infected;

⁃ A cross-sectional area of between 1 and 25 cm2 post-debridement;

⁃ Present for at least 4 weeks before randomization;

• If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit;

• Able and willing to attend the scheduled visits and comply with study procedures.