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