DermaCELL vs. Integra Study (H-42282)
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33 percent of all direct costs of diabetes care in the US. Once the skin is ulcerated, it is susceptible to becoming infected and ultimately amputation in particular in the case of deep DFUs. To manage the cost and avoid hospitalization and amputation, wounds should be immediately closed. However, this is often challenging in diabetic foot with deep ulcers. The primary objective of this study is to compare the outcomes of DermaCELL with Integra, two different ECM grafts. We assumed that the wound’s outcomes (e.g. weekly wound size change, time to heal, time to successful wound granulation) are comparable between DermaCELL and Integra, making both of these grafts a feasible option in the treatment of DFUs.
Patients with diabetes
Non-infected deep wounds
18 years or older
Gangrene or osteomyelitis
Major vascular problems (ABI<0.5 or > 1.3)