Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

Inclusion Criteria: * The subject has: 1. been diagnosed with Diabetes Mellitus (insulin or non-insulin dependent) and peripheral neuropathy (loss of protective sensation) in affected foot 2. a HbA1c of less than 10% assessed within last 12 weeks 3. a full-thickness diabetic neuropathic foot ulcer that is free from tunnels/sinus tracks, necrotic tissue, exposed bone and/or tendon, and osteomyelitis post debridement (Wagner 1 or 2; Appendix I) 4. one (target) diabetic neuropathic foot ulcer of less than 12 months duration that has an area that measures ≥ 1.5 and ≤ 10 cm2 post debridement (max length x max width) at screening that is on any surface and part of the foot (fore-, mid- or hind-foot) with an etiology related to loss of protective sensation in that foot. 5. a target ulcer that closed \<30% during the 2 week run-in period (2 weeks management with SOC following signature of informed consent prior to potential randomization) 6. sufficient arterial supply to affected foot tested within the past 60 days Exclusion Criteria: * The subject has: 1. ulcers of non-diabetic etiology on the study foot 2. a target ulcer clinically infected or has underlying osteomyelitis at time of study treatment initiation 3. clinical evidence of gangrene on any part of the affected foot 4. a target ulcer with exposed bone or tendon 5. any malignancy or a neoplasm at the target ulcer site 6. active Charcot Foot or Charcot Foot that is unable to be offloaded (stable, non-active Charcot deformity that is able to be offloaded is acceptable) 7. more than 3 ulcers on the study foot, including the target ulcer, and all other ulcers must be at least 3 cm removed from the target ulcer 8. any significant comorbid disease that may interfere with wound healing 9. received chemotherapy, radiotherapy, immunosuppressant or corticosteroid (greater than 10 mg prednisone-equivalent per day) within the past 30 days. 10. had the diabetic foot ulcer treated with an experimental drug/biologic/device, or a live-cell therapy (experimental or marketed), or active moist wound healing therapy within 30 days of randomization day