A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

Major Inclusion Criteria:

• Subject has a current diagnosis of type I or type II diabetes
• Subject's ulcer is on the forefoot or heel
• Subject has chronic ulcer - has been present for minimum of 4 weeks
• Subject's ulcer extends through the dermis and into the subcutaneous tissue
• Subject's HgbA1c <12%
• Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Major Exclusion Criteria:

• Subject has a known sensitivity to bovine- or porcine-derived products.
• Subject's ulcer is due to a non-diabetic etiology
• Subject's ulcer is over a Charcot deformity of the mid-foot
• Subject's random blood sugar readings are >450 mg/dL
• Subject is on dialysis
• Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer