SANUWAVE, Inc. (SANUWAVE), medical technology company developing products for wound care, has initiated a clinical trial for dermaPACE in Southern Arizona VA Medical Center in Tucson, Arizona. The trial will evaluate Pulsed Acoustic Cellular Expression (PACE) technology and the safety and efficacy of dermaPACE in healing diabetic foot ulcers.
Patient enrollment for the dermaPACE trial for healing diabetic foot ulcers recently reached 75% completion. With 19 other trial sites in the US and two international sites in the United Kingdom and Germany, the Southern Arizona VA site becomes the twenty-second site that is actively recruiting subjects for the dermaPACE trial. The objective of this clinical study is to compare the safety and effectiveness of the dermaPACE device to sham application, when administered in conjunction with the standard of care, in the treatment of diabetic foot ulcers. It is a randomized, double blind, placebo control, parallel assignment study design. Other notable wound care institutions that are actively involved in the trial include Calvary Hospital in New York, North American Center for Limb Preservation in New Haven, Connecticut, Boston Medical Center, Phoenix VA, VA Long Beach, California, Northwestern University in Chicago, The Ohio State University Medical Center in Columbus, King’s College Hospital in London, and Emory Orthopedics and Spine Center in Atlanta.
Katherine Neiderer, DPM said: “With diabetic foot ulcers afflicting a growing number of diabetic patients, often resulting in loss of limbs, I am pleased that our center has become part of the dermaPACE clinical trial, as it offers a potential and promising solution for those patients.”
Christopher M. Cashman, President and CEO of SANUWAVE said: “We are very encouraged by the support that the wound care medical community has shown our dermaPACE trial and their continued desire to join as the study nears its final enrollment stage. As our clinical trial continues, we believe that we are getting closer to being able to offer the healthcare community and the patients who suffer from an estimated 1.5 million diabetic foot ulcers in the US alone, a unique solution to a demanding medical problem at a reasonable cost.”