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Sanuwave completes patient follow-up in phase 3 trial of diabetic foot ulcer treatment
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Sanuwave Health, Inc. a medical technology company focused on noninvasive, biological-response activating devices in regenerative medicine, announced in a press release the completion of patient follow-up in the company’s pivotal phase 3, Investigational Device Exemption (IDE) clinical trial with dermaPACE for the treatment of diabetic foot ulcers.
A total of 206 patients were enrolled in the 26-week, prospective, randomized, double-blinded, sham-controlled trial, which was conducted at 22 U.S. sites and two sites in Western Europe. The goal of the study is to establish superiority in diabetic foot ulcer healing rates using the dermaPACE treatment compared with sham control, when both are combined with the current standard of care, according to the press release.
The dermaPACE incorporates the Sanuwave’s PACE (Pulsed Acoustic Cellular Expression) technology platform, which delivers a proprietary form of extracorporeal shock wave therapy (ESWT) to treat a wide variety of chronic and acute soft tissue conditions, the company noted.
Sanuwave estimates a submission of the final Premarket Approval (PMA) module to the Food and Drug Administration (FDA) late in 2010 or early in 2011.
Christopher M. Cashman, Sanuwave president and CEO, stated in the release, “Despite advances in diabetes management, diabetic foot ulcers continue to be the most common cause of hospitalization among diabetics, and diabetes remains the single largest contributing factor to limb loss. Estimates indicate people with diabetes have a 25% lifetime risk for developing a foot ulcer, with half of these ulcers becoming infected. Of these infected ulcers, one in four will lead to amputation. Early detection and appropriate treatment of diabetic foot ulcers may eliminate the vast majority of amputations. The dermaPACE, with its novel biologic regenerative effects, holds promise to heal diabetic foot ulcers and increase limb preservation, thus improving quality of life for these patients and their families and significantly easing the economic burden on an overwhelmed health care system that cares for these patients.”