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

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,