GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

Inclusion Criteria: * Type 1 or Type 2 Diabetes * Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks) * Index ulcer located below the malleoli on the plantar or dorsal surface of the foot * Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule * Adequate circulation to the foot (documented by ABI or TBI) Exclusion Criteria: * Gangrene present on affected foot * Index ulcer is over a Charcot deformity * Patient is receiving dialysis * Patient has 2 or more previous amputations * Patient has HbA1c \>12% or random blood sugar \>450 mg/dl * Chronic oral steroid use * Use of IV corticosteroid, immunosuppressive, or cytotoxic agents * IV antibiotics * Another ulcer within 5cm of the Index ulcer * Cellulitis, evidence of infection, or osteomyelitis