The Amputee Coalition announced that it has urged the U.S. Food and Drug Administration (FDA) to finalize draft guidance that would ensure transparency and efficacy of chronic wound care products used to treat millions of Americans at risk for amputation due to non-healing wounds like diabetic foot ulcers (DFUs).
“As the nation’s leading advocate for amputees and those at risk of limb loss, we believe that transparency related to any product-including wound care and healing-is critical for people making decisions about care. The FDA’s proposal on wound care products would ensure patients and providers have the information they require to confirm that marketing claims are substantiated and adequate care is provided,” said Jack Richmond, interim president and CEO for the Amputee Coalition. “Lack of transparency, regulatory clarity, and enforcement poses significant challenges for patients who need to rely on safe and effective therapies to achieve wound healing and avoid lower-limb amputation.”
The Amputee Coalition’s 2016 white paper, published by its Limb Loss Task Force, highlights the fact that vascular disease, including diabetes, is the leading cause of limb loss in the United States. The Centers for Disease Control and Prevention (CDC) estimate 29.1 million Americans have diabetes, which can result in life- and limb-threatening DFUs. About 73,000 amputations are performed annually on U.S. patients as a result of non-healing DFUs, according to the white paper.
