The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

Inclusion Criteria:

- Adult Type 1 or 2 diabetic patients that present with foot ulcers.

- Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.

- Ulcer depth: Full thickness (absence of all epithelial layers or deeper)

- Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)

- All ulcer durations will be eligible

- Patients currently receiving NPWT for a diabetic foot ulcer

- Patients must be appropriate NPWT candidates and be willing and able to sleep,
ambulate, and rest with the NPWT unit in place.

Exclusion Criteria:

- Active foot infections

- Presence of any serious disease including end-stage renal failure requiring dialysis
or renal transplantation or active malignant disease requiring treatment which
seriously compromises the patient's ability to complete this study

- Patients who are pregnant

- Allergies to any material contained within the NPWT or bioscaffold

- Any condition that would exclude NPWT use including but not limited to active
bleeding, presence of malignancy in the wound or inability to follow any of the NPWT
safety guidelines