Patients with diabetes are at risk for developing serious health problems that may affect the feet, eyes, kidneys, skin and heart. Foot ulcerations are one of the most common and serious complications in patients with diabetes. The development of DFUs can result from peripheral neuropathy and/or blood vessel disease, but the most common cause is peripheral neuropathy complicated by deformity, callus, and trauma. Vascular insufficiency, infection and failure to implement effective treatment for DFUs are linked to secondary medical complications such as osteomyelitis and amputation. Up to 25% of diabetics can expect to develop a foot ulcer at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%. More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5 will require amputation.
Foot ulcers account for 85,000 nontrauma related lower limb amputations annually. It is estimated that every 20 seconds, somewhere in the world, a limb is lost as a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States each year occurs secondary to complications of diabetes mellitus. After a major amputation, 50% of patients will have another limb amputated within two years. Mortality rates subsequent to amputation are alarmingly high… up to 40% at 1 year and 80% at 5 years. Patients with a history of a diabetic foot ulcer have a 40% greater mortality rate compared to patients with diabetes alone. These alarming statistics demonstrate the compelling need for new therapies to treat DFUs.