BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers

Inclusion Criteria: * Male or female, at least 20 years of age (inclusive) at the date of Screening * Subject or legally authorized representative who is able to understand the nature of this study and accepts to enter the study by signing written informed consent * Subject agrees to comply with ulcer care regimen for the duration of the study and is willing to return for all mandatory visits as defined in the protocol * Subject with Type 1 or Type 2 diabetes mellitus (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) and is under the care of a physician for the management of diabetes mellitus * Subject with glycosylated hemoglobin (HbA1c) ≤ 12% * Subject with at least one diabetic foot ulcer meets the following criteria at Screening Visit: i. Located below knees; ii. Not healing for ≥ 4 weeks prior to Screening Visit despite appropriate care; iii. Ulcer size of ≥ 0.5 cm2 to ≤ 10 cm2 measured by the electronic measuring device following sharp debridement (if necessary) at Screening Visit and reconfirmed at Randomization Visit; iv. The largest ulcer will be selected as target ulcer. If ≥ 2 ulcers have the largest size, the one with the worst grade by Wagner Classification will be selected. If ≥ 2 ulcers have the largest size and grade, the one with longest duration will be selected; v. The target ulcer is classified as Grade 1 to Grade 2 according to Wagner Classification System for diabetic foot ulcer; vi. The target ulcer should be without…