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Drexel University researchers are one step closer to offering a new treatment for the millions of patients who suffer from slow-healing, chronic wounds. The battery-powered applicator — as small and light as a watch — is the first portable and potentially wearable device to heal wounds with low-frequency ultrasound.

The National Institutes of Health (NIH) has awarded the research team an estimated $3 million to test the therapy on 120 patients over the next five years. By using diagnostic monitoring of blood flow in the wound tissue, the clinical trial will also determine how nutrition and inflammation impact wound closure, making treatment customization a possibility.

The project is an interdisciplinary collaboration between Drexel’s School of Biomedical Engineering, Science and Health Systems, the College of Medicine and the College of Nursing and Health Professions.

“There is no other existing treatment you can compare it with,” said Peter Lewin, PhD, the project’s principal investigator and the Richard B. Beard Distinguished University Professor in the School of Biomedical Engineering, Science and Health Systems. “If we can prove this is effective for a large group of patients, then we have the potential to solve a very costly and debilitating health problem.”

Chronic wounds affect up to 6 million patients per year in the United States. Venous ulcers — one type of chronic wound the researchers will explore — are caused by abnormal vein function, due to blood clots, injury, aging and obesity. Chronic wounds are also some of the most dangerous and common complications of diabetes. Unlike a typical scrape or cut, venous and diabetic ulcers can take months, or even years, to heal. The only methods currently available to treat chronic wounds are passive, rather than active, such as using products to keep moisture in place, among other therapies.

Because of their high prevalence, chronic wounds are a significant economic burden to the U.S. health care system. Over $20 billion annually is spent on the treatment of chronic wounds in the United States, according to some estimates. Treatment can cost an individual patient up to $2,400 per month, so even modest reductions in healing time would help, according to Michael S. Weingarten, MD, professor of surgery at the College of Medicine and medical director of the Comprehensive Wound Healing Program at Drexel.

“There is a lot of money being spent on wound supply, visiting nurses and things like that. Those costs can run into the hundreds of thousands of dollars for an individual patient,” Weingarten said. “And if the wound isn’t responding, then you’re really just wasting your time, and more importantly, you’re not helping the patient.”

Biomedical engineers and clinicians at Drexel have an ideal solution: an inexpensive, portable instrument that can speed up slow-healing injuries and is safe enough for patients to use at home.

The device heals by sending low-frequency — 20 kilohertz (kHz) — ultrasonic sound waves directly to the chronic wound. While the healing potential of ultrasound to reduce swelling in injury is well known, high energy levels are not optimal for treating damaged tissue over long periods of time.

“We know the interaction of ultrasound and biological tissue can lead to undesirable effects, and we want to make sure that if we have a device that is helpful for patients, it must be foolproof,” Lewin said. “It must be absolutely safe, even if a patient would inadvertently apply the treatment for 24 hours.”

The device Lewin and his colleagues have developed operates at a level of energy much lower than the ultrasound units used to monitor pregnancy. Once the device is fully developed, the applicator may be applied directly to the wound using a thin piece of tegaderm, gel and medical tape. Then, with the flip of switch, the palm-sized battery pack is turned on, driving the set of transducers inside the device to create acoustic energy and begin the wound-healing process.

Since the device is compact, lightweight and portable, patients may one day be able to use it in their homes, avoiding the high costs and other inconveniences associated with frequent doctor’s office visits.

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