Usually wound therapies are treatments that include some sort of external component to help a patient heal. Sanuwave (Alpharetta, Georgia), a developer of noninvasive, biologic response activating devices in the regenerative medicine segment, is looking at going against conventional woundcare therapy logic and has developed an application that will stimulate the body's own natural ability to heal.
With dermaPACE, (Pulsed Acoustic Celluar Expression), the company is seeking to obtain an investigational device exemption from the FDA in looking at the safety and efficacy of the device in healing diabetic foot ulcers. The company reported adding its 22nd site to a clinical trial for dermaPACE last week.
"Instead of trying to deal with healing externally, we're actually trying to stimulate the body's own healing ability," Christopher Cashman, president/CEO Sanuwave, told Medical Device Daily.
The device delivers pulsed acoustic energy waves to the affected area of the patient Cashman said, adding this energy is what stimulates the healing process.
The enrollment for the dermaPACE trial for healing diabetic foot ulcers recently reached 75% completion. With 19 other trial sites in the U.S. and two international sites in the UK 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. The company said that 200 patients would be involved in the clinical study.
"So what would happen would be, a patient would come in, the physician would clean the affected site, apply gel and fire about five hundred pulses to the affected area," he said.
Patients in the active study arm receive four treatments over a two week period of pulsed acoustic energy waves to their wound.
"Each patient is different but we believe the body will respond adequately after the four treatments," Cashman said.
The trial is set to end sometime next year, with the company hoping to launch the device in the U.S. in 2011. The device was already cleared in Europe.
The company believes the device will have a tremendous impact in the diabetic illness market. According to the American Diabetes Association (Alexandria, Virginia), 23.6 million people in the U.S. suffer from diabetes and another 57 million are pre-diabetic.
The National Institutes of Health (NIH) reported that 15% of people with diabetes will acquire a non-healing ulcer in their lifetime, and chronic leg wounds (ulcers) are estimated to account for the loss of two million workdays a year at a cost of nearly $300 million in lost productivity. Diabetic foot ulcers are a recurrent condition and lead to more than 82,000 amputations annually. The Advanced Medical Technology Association (Washington) estimates it costs roughly $60,000 for a lower limb amputation that can result from a diabetic foot ulcer, representing an annual cost of $5 billion. Hospitalization costs alone for a patient with a diabetic foot ulcer can reach $16,000-$20,000 annually.
"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," Cashman said. 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 U.S. alone, a unique solution to a demanding medical problem at a reasonable cost."
Sanuwave was founded in 2005 and has a portfolio of products for the biologic signaling and angiogenic responses to restore the bodies natural healing process. The company already has a U.S. Class III PMA approval for its OssaTron device which stimulates healing in the foot and the elbow.