Of the 20 million Americans suffering today from diabetes, one million will probably be killed by their feet. A diabetic foot ulcer and its attendant complications constitute a surer death sentence than colorectal cancer—just over half of all diagnosed patients survive for five years. More startling than these statistics, however, is that for 40 years, physicians have known about a safe medical procedure to prevent these ulcers. But the U.S. Food and Drug Administration has yet to approve the treatment.

Diabetics develop foot ulcers because of nerve damage. Injury to motor neurons deforms the feet, creating pressure points that are susceptible to harm during walking, and damage to sensory neurons prevents patients from feeling anything. “They lose the gift of pain,” explains David Armstrong, a surgeon and a podiatric medicine expert at Rosalind Franklin University in Chicago. Unaware that anything is wrong, patients continue to walk and end up wearing out the protective fat pad between the skin and the bone in those areas. Eventually the skin erodes away, and an ulcer forms. They  “wear a hole in their foot just like you or I might wear a hole in our shoe,” Armstrong says. Left untreated, an ulcer can become infected or gangrenous and can lead to foot or leg amputation—if it does not cause sepsis, a blood infection, first.