Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue

Inclusion criteria

• ✓. Age ≥ 18 years
• ✓. Patient has current diagnosis of type 1 or type 2 diabetes mellitus
• ✓. Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
• ✓. Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
• ✓. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
• ✓. For female patients of childbearing potential, commitment to using a medically accepted means of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout study period and tests negative on a pregnancy test
• ✓. Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment
• ✓. Able and willing to wear an off-loading device or orthopedic shoe

Exclusion criteria