Skin Regeneration System Treats Diabetic Foot Ulcers

Once in direct contact with the excised wound or ulcer, it provides immediate wound closure and acts as a scaffold for cell migration, allowing for permanent regeneration of the dermal layer of the patient's skin.

The FOot Ulcer New DErmal Replacement (FOUNDER) study, a recent randomized clinical trial that enrolled 307 patients at 32 sites that was conducted under an investigational device exemption (IDE) issued by the US Food and Drug Administration (FDA), showed that patients treated with IDRT demonstrated a 59% improvement in the incidence of complete wound closure when compared to standard of care. The study was published in the November/December 2015 issue of Wound Repair and Regeneration.

“Integra is pleased to announce the approval of IDRT for the treatment of diabetic foot ulcers,” said Peter Arduini, President and CEO of Integra LifeSciences. “This approval allows us to provide clinicians and their patients with a product backed by a robust clinical trial to treat the nearly one million non-healing DFUs that will occur this year.”

“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," said William Maisel, MD, acting director of the FDA Center for Devices and Radiological Health (CDRH). “The Dermal Regeneration Template was previously approved for treating life threatening burn injuries and burn scars when the use of a patient's own skin for a graft is not possible.”

The nerve pathways that ensure that weight is automatically transferred from one foot to the other during prolonged standing are disrupted in diabetics, and as a result, they do not notice that their toes, heels, or the balls of their feet are too heavily loaded. The foot receives no relief, and pressure sores, ulcers, and infections may go unnoticed, leading to nerve and circulation problems in the feet, which reduce their perception of pain. Serious cases may even lead to amputation.

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