A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers

Phase IV Prospective, Multi-Center, Randomized, Single-Blind, Active and Standard Care-Controlled Study of DermaPure™ in Patients With "Hard to Heal" Chronic, Neuropathic Diabetic Foot Ulcers With Crossover Design for Standard Care Arm

This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.

DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to "hard to heal" chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.

Inclusion Criteria:

• Type 1 or Type 2 diabetes with HbA1c ≤12%
• Adequate perfusion
• A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification.
• Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.

Exclusion Criteria:

• BMI greater than 45kg/m2.
• Presence of infection
• Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement.
• A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient.
• Therapy with any investigational agent or drug within 4 weeks preceding the screening visit.
• More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment.
• Evidence of malnutrition as confirmed by serum pre-albumin level at screening.
• Evidence of drug or alcohol abuse,