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