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

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,