GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.

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