A new treatment option for patients with non-healing diabetic foot ulcers has been approved by the US Food and Drug Administration (FDA).
Up to 10 per cent of people with diabetes develop a foot ulcer at some point, which is closely linked with diabetic neuropathy, diabetic nerve pain and diabetes foot care.
The worst scenario for a foot ulcer can be amputation, while less serious foot ulcers can take a long time to heal and be extremely uncomfortable to live with.
The device is the Integra Dermal Regeneration Template (IDRT), developed by Integra LifeSciences, but will be marketed under the name Integra Omnigraft Dermal Regeneration Template.
It has been approved to treat diabetic foot ulcers that last longer than six weeks and, in conjunction with standard diabetes care, do not involve exposure of the joint capsule, bone or tendon.
Once placed over the ulcer, the Omnigraft device is designed to provide immediate wound closure and permanent dermis regeneration. The device – made up of silicone, cow collagen and shark cartilage – acts as a scaffold for cell migratio, allowing new skin and tissue to grow.
The FDA approved Omnigraft following a 16-week trial – the Foot Ulcer New Dermal Replacement (FOUNDER) Study. The results showed that IDRT produced wound healing in 51 per cent of patients after 16 weeks compared to 32 per cent who received standard care. There was also a 59 per cent improvement in the incidence of complete wound closure among Omnigraft participants.
Omnigraft should not be used by patients with infected wounds or those allergic to cow collagen or chondroitin. Adverse reactions in the FOUNDER study included infections, nausea and swelling.
William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Centre for Devices and Radiological Health, said: “We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal. Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”
Peter Arduini, Integra’s President and Chief Executive Officer, added: “Integra is pleased to announce the approval of IDRT for the treatment of diabetic foot ulcers.
“This approval allows us to provide clinicians and their patients with a product backed by a robust clinical trial to treat the nearly 1 million non-healing DFUs that will occur this year. This significant milestone enables us to remain on track for DFU market commercialisation in mid-2016.”
