Home Caregiver Helping Senior Woman To Bandage Her Injured Ankle.

One-third of patients hospitalized for a diabetic foot infection require amputation, and nearly half of those die within five years.

But soon-to-be-issued guidelines from the US Food and Drug Administration could prompt the development of new drug treatment options, according to a March article in JAMA. The new drugs would be designed with antimicrobial resistance in mind, meaning they must limit bone and joint involvement, according to a draft issued last fall.

“We do not have a lot of options for our patients,” David Armstrong, MD, PhD, a podiatric surgeon at the University of Southern California and DFU researcher told JAMA. “Sometimes we’re treating people with drugs that are 50 or 60 years old and are grossly ineffective, and even harmful.”

The FDA’s goal is to entice drugmakers to bring safe, effective drugs to market, either as intravenous or pill-based treatments. Draft guidance encouraged the inclusion of obese patients and geriatric patients “without any upper age limit” in clinical trials. It also encouraged testing among patients with comorbidities common among patients with diabetes and wounds.