One fourth of the approximately 22.3 million patients with diabetes in the United States are expected to develop a diabetic foot ulcer (DFU) at some point during their lives, and it is estimated to affect 1-8% of individuals with diabetes annually. DFUs have shown to be challenging to treat, and often result in extended hospital stays, increased risk of infection, and subsequent amputation in certain patients. A major concern regarding amputees is a 5-year mortality rate that rivals that of patients with colon cancer. In addition, DFUs contribute heavily to the financial load of payers, with an estimated annual medical cost of up to $13 billion.
Prior studies have indicated that wounds that penetrate bone, are prolonged and recurrent, and those associated with peripheral vascular disease pose a great risk for eventual amputation. Studies have shown that, even with proper care of DFUs by podiatric physicians and other clinical personnel, these wounds are slow to heal. Advanced therapies are often explored to improve outcomes.