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FDA Approves First Shock Wave Device To Heal Foot Ulcers In Diabetes Patients

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Federal health regulators have green-lighted the use of the first shock wave device that promotes healing of foot ulcers in patients with diabetes.

Dermapace System

In a news release published Dec. 28, the U.S. Food and Drug Administration announced that it now approves the marketing of the Dermapace System designed as treatment for diabetic foot ulcers, where damage to nerves and blood vessels may lead to reduced circulation, infection, and even amputation.

How It Works

The device is intended to treat chronic, full-thickness diabetic foot ulcers whose wound areas measure no bigger than the size of a soda can top. It is for use by adult patients suffering from diabetic foot ulcers that last for more than a month. The therapy should be used with standard diabetic ulcer care.

The Dermapace System works by using pulses of energy similar to sound waves to mechanically stimulate the wound and promote healing.

Shock Wave Device Increases Wound Healing

Investigators conducted two double-blind studies involving diabetic patients who received the usual care only, usual care plus the Dermapace System, or usual care plus non-working Dermapace System.

Results showed an increase in wound healing in those who received between one and seven Dermapace System therapy after 24 weeks. They also had 44 percent wound closure rate over this period. In comparison, those who were treated with the fake system only had 30 percent closure rate.

"The U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers," the FDA said in a statement.

Side Effects

Common side effects of using the device include pain during its application, local numbness and bruising, nausea, wound infection, fainting, infection beyond the wound, and fever.

Diabetes And Amputations

Diabetes is the number 1 cause of lower limb amputations. Figures from the U.S. Centers for Disease Control and Prevention show that there are about 30.3 million people in the United States diagnosed with diabetes. Of these, 25 percent will experience a foot amputation, which could be deemed necessary in certain instances such as when circulation has become so poor or the ulcer fails to heal or treatment has failed to stop the spread of infection.

"Nerve damage, circulation problems, and infections can cause serious foot problems for people with diabetes," CDC said. "Poor circulation can make these injuries slow to heal. Sometimes this can lead to amputation of a toe, foot, or leg."

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