On May 8, an advisory panel of the U.S. Food and Drug Administration (FDA) recommended approval of the bioengineered skin substitute Apligraf.
Manufactured by Organogenesis Inc., Apligraf is intended for use in the treatment of diabetic foot ulcers of greater than two weeks duration. Apligraf has already been given FDA clearance for the treatment of venous leg ulcers.
Foot Ulcers Can Lead to Amputation
Between 600,000 and 800,000 people in the United States currently suffer from diabetic foot ulcers. This foot complication is a potential cause of amputation and is the most frequent cause of hospitalization among people with diabetes. Diabetic foot ulcers are estimated to cost the U.S. health care system over $1 billion per year.
56 Percent of Diabetic Foot Ulcers Healed
The Apligraf diabetic ulcer pivotal trial was a large, prospective, randomized, multi-center study. For the study, 208 patients were treated with either Apligraf plus standard care or diabetic ulcer standard care alone.
Use of Apligraf healed 56 percent of ulcers within 12 weeks, compared to 38 percent healing with standard care alone. Use of Apligraf was also found to reduce time of healing. Complete healing was achieved in an average of 65 days with Apligraf, compared to 90 days with standard care alone.
Apligraf plus standard care was not associated with any significant side effects.
For more information, call Organogenesis 781-575-0775