FDA indicates Omnigraft wound dressing for treatment of diabetic foot ulcers
The product facilitates the growth of new skin and tissue while it heals the ulcer wounds.
"We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal," Dr. William Maisel, acting director of the FDA's Office of Device Evaluation, said. "Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities."
The Omnigraft dressing is indicated for use on foot ulcers that have lasted longer than six weeks and in which the joint capsule, tendon or bones are not exposed. It is meant to be used in conjunction with other typical methods of care, not as a sole therapy.
Statistics from the U.S. Centers for Disease Control show that, of the 29 million people in the U.S. who have been diagnosed with diabetes, a quarter of them will suffer from foot ulcers, which can lead to bone infections and amputations.
Omnigraft products were first approved by the FDA in 1996 to be used in the treatment of life-threatening injuries. The products were approved for use in reconstructive surgery and burn injuries in 2002.
Studies showed that after 16 weeks of treatment, 51 percent of patients treated with the Omnigraft experienced healing of their foot ulcers. The percentage of patients who experienced healing with standard ulcer care without the Omnigraft was 32.
Organizations in this story
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD - 20903