The primary objective of the present study is to further establish in a randomized controlled
trial, the safety and efficacy of weekly Grafix® administration versus control in patients
with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the
index wound, defined as 100% re-epithelialization as determined by the Investigator.
Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue
Based Product (HCT/P) under Title 21 CFR Part 1271.