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