SANUWAVE Health, Inc., (OTC BB: SNWV), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, today announced that patient enrollment was completed in March in its dermaPACE™ Phase III pivotal, 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).
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 United States, 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, Northwestern University in Chicago, VA Long Beach, California, The Ohio State University Medical Center in Columbus, King's College Hospital in London, Emory Orthopedics and Spine Center in Atlanta, Calvary Hospital in New York, and the North American Center for Limb Preservation in New Haven, Connecticut. 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.
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. The Company plans to announce 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.
Vickie R. Driver, DPM, a principal investigator in the dermaPACE™ trial and Associate Professor of Surgery at Boston University School of Medicine said, "Completing patient enrollment for the dermaPACE™ trial is a major accomplishment for SANUWAVE and all the participating study sites. Diabetic foot ulcer trials can be especially difficult from a patient enrollment standpoint because diabetic patients are often very sick and cannot participate in a trial. It is not often that a company in the chronic wound market undertakes such an ambitious enrollment target in this patient population, let alone achieves it. As an investigator in this trial, I am encouraged by the high enrollment number, as the dermaPACE™ holds promise to significantly improve our traditional outcomes for closing diabetic foot ulcers and preserving limbs. dermaPACE™ is a novel, advanced wound healing modality - yet it is also easy to administer and adaptable to almost any clinical care environment. I look forward to seeing the final data as soon as it is available."
Christopher M. Cashman, President and CEO of SANUWAVE, said, "I am encouraged and deeply grateful for the dedication and passionate commitment of our study sites. 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. We will continue to be aggressive with our timelines, as the medical need is well-documented, urgent and growing. In the U.S. alone, there are up to 3 million foot ulcers in any given year. And with 27 million diabetics in the U.S. and 54 million that are pre-diabetic, this disease state is only getting worse. Unfortunately, the occurrence of diabetes onset is also on the rise in many other countries, making our mission one of global importance. The United States diabetic foot ulcer market is estimated to be approximately a $2 billion portion of the estimated $10 billion global advanced wound care market."
Mr. Cashman continued, "Foot complications are the most frequent reason for hospitalization in patients with diabetes, accounting for up to 25 percent of all diabetic admissions in the U.S. This places a tremendous burden on available healthcare resources and seriously diminishes quality of life for patients and their families. Early detection and appropriate treatment of diabetic foot ulcers may eliminate the vast majority of amputations. As shown in our complete body of clinical work, dermaPACE™ has been able to efficiently promote wound closure, and to provide treatment in a convenient, flexible and cost-effective manner that encourages both the caregiver and the patient to adopt dermaPACE™ into their standard of care. Our high enrollment of 207 patients in the dermaPACE™ multicenter diabetic foot ulcer trial is another positive indicator that dermaPACE™ treatment can be successfully incorporated into the clinical care system."
Study Design
The objective of the dermaPACE™ clinical trial is to compare the safety and effectiveness of the dermaPACE™ device to sham control, when administered in conjunction with the standard of care, in the treatment of diabetic foot ulcers. It is a randomized, double-blind, sham controlled, multicenter, 26-week, parallel assignment study design with a primary endpoint of diabetic foot ulcer closure at 12 weeks following the first treatment application. Secondary endpoints include time to closure, reduction in total wound surface area and volume, long-term safety, and skin appearance and pain assessments.
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