SanuwaveHealth, focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, has completed patient enrollment in dermaPACE Phase III pivotal trial.
The trial was a randomized, double-blinded, sham controlled, multicenter clinical trial comparing its Pulsed Acoustic Cellular Expression (PACE) technology, utilizing the dermaPACE tissue regeneration device, to sham control for the treatment of diabetic foot ulcers (DFU).
SanuwaveHealth said that the primary study goal is to establish superiority in diabetic foot ulcer healing rates using the dermaPACE treatment compared to sham control, when both are combined with the current standard of care. The standard of care includes wet-to-dry dressings, the most widely used primary dressing material in the US, and offloading with a walking boot.
A total of 207 patients have entered the dermaPACE study at 24 sites, including Boston Medical Center, Phoenix VA and etc., The principal investigators in the study represent the multidisciplinary nature of treating chronic wounds, including specialties such as vascular surgery, plastic surgery, podiatry and endocrinology.
SanuwaveHealth said that the study patients must be followed a total of 24 weeks. The study’s primary endpoint, wound closure, is defined as ‘successful’ if the skin is reepithelialized without drainage or dressing requirements confirmed at two consecutive study visits. Final study data including time to closure, total wound size reduction, long-term safety, and study subject assessments is expected to be available by the fourth quarter of this year.
SanuwaveHealth plans to present a summary of the top-line data immediately following validation of study results and statistical analysis. In addition, the company is finalizing its regulatory submission plan with the FDA and will provide further information when the plan is established.
Christopher Cashman, president and CEO of Sanuwave, said: “Enrollment in 2010 has been strong, and we reached our target patient enrollment earlier than expected in the first quarter of this year. This significant milestone will allow us to unblind and analyze the data and report on it, with our expectation to file our regulatory submission in 2010.”