Diabetes is a painful disease for a whole host of reasons, but an often overlooked ailment is diabetic foot ulcers. Both excruciating and debilitating, diabetic foot ulcers are difficult to take care of and an effective treatment plan has been hard to come by. Which is why the news that the FDA has approved the Omnigraft Dermal Regeneration Matrix, generally just called “Omnigraft,” for treatment of diabetic foot ulcers comes as great news.
Of the estimated 29 million in the United States that live with diabetes nearly a quarter of them will suffer from foot ulcers at some point during their lifetime. While foot ulcers are excruciating and unpleasant on their own, they can lead to even worse ailments like tissue and bone infections, and result in 50,000 amputations each year.
Omnigraft, which is developed by Integra LifeSciences, is made of silicon, cow collagen, and shark cartilage. It could radically increase the chance of patients with diabetic foot ulcers recovering from the injury. The matrix device works by creating a clean environment over the foot ulcer where the skin can regenerate and heal.
A new study on Omnigraft demonstrated that the graft skin is far more effective at treating foot ulcers than standard treatment, which generally consists of simply cleaning the wound, covering it with surgical bandages, and keeping weight off of it for a while. After a 16 week period, 51 percent of patients whose foot ulcers were treated with Omnigraft recovered, a significant step up from the mere 32 percent who recovered in that time when given the traditional treatment for foot ulcers.
“We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal,” said William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”
Although Omnigraft just got approved for treatment of foot ulcers, the matrix device has actually been around for a while. Omnigraft was first approved in 1996 for the treatment of life threatening burn injuries when a patient’s own skin was not available for the graft. Since then it has also been used in reconstructive surgery for victims of severe burns. Hopefully the newly approved treatment will provide as much relief for those suffering from foot ulcers as it has for burn victims.