FDA Approves Shock Wave Device for Diabetic Foot Ulcers

Shock-wave system closes wounds better after 1 to 7 sessions that not using it, experts found.

FDA Approves Shock Wave Device for Diabetic Foot UlcersSanuwave’s Dermapace system is a handheld wand attached to a larger central unit that work in tandem to expedite healing in patients who suffer from diabetic foot ulcers.


It's sobering but true. One in four people with diabetes will develop a foot ulcer in their lifetime, and these wounds can be serious, sometimes requiring amputation if healing doesn't occur or infection sets in.

Now, a new treatment just approved by the FDA promises to shorten wound healing time. Called the dermaPACE System, it uses shock waves to stimulate wounds mechanically, helping them to heal. It is the first FDA shock wave device OK'd to treat diabetic foot ulcers.

More About the System

The system will be rolled out in some areas of the U.S. by late March, says Lisa Sundstrom, chief financial officer at Sanuwave, the company that developed it. Full distribution across the country is expected by October.

The system will be sold to podiatrists, wound care centers and physicians, Sundstrom tells OnTrackDiabetes. The exact cost of the device, which will be used only in health care offices, is not yet available, she says. The company is in discussions to obtain a specific reimbursement code for the treatment so it can be covered by insurance, she says.

The FDA's Review

The FDA approved the device in late December after looking at two randomized clinical trials with a total of 336 patients. All those studied had diabetes—some well-controlled and some poorly controlled—and foot ulcers. They all received standard care, which includes either removal of damaged tissue (debridement) or wet-to-dry dressings. Then they were also assigned to get either the shock wave therapy or a sham (non-working) shock wave therapy treatment. The participants didn't know if they were getting the real shock wave treatment or the non-working one.

Those who got between one and seven treatments with the system showed better wound healing, with a 44% closure rate of the wound at week 24. The group getting sham shock wave therapy had a 30% wound closure rate at week 24.

The treatment uses pulses of energy somewhat like sound waves to mechanically stimulate the wound and promote healing. The FDA Ok'd its use for those age 22 and older who have had diabetic foot ulcers for more than 30 days.

Side effects included pain when the device was applied, local bruising and numbness, nausea, fainting, wound infection, infection beyond the wound, migraines, and fever.

The device is meant to be used in foot ulcers with areas no larger than about 2.5 inches squared, or about the size of a soda can top.

Experts' Views

The results look promising, says Bela Pandit, DPM, a foot and ankle surgeon in Evergreen Park, Il. She reviewed the data for OnTrackDiabetes.

''Shock wave therapy is used a lot in our field," she tells OnTrack  Diabetes. Among the uses of other shock wave treatments, she says, are treating tendinitis, muscle pain and plantar fasciitis (a painful inflammation of the tissue stretching from the heel bone to the base of the toes).

"It would be very feasible to use the technology on a wound," Dr. Pandit says. "Wounds can drag on for a very long time, and anything that can shorten the healing time is promising."

However, she cautions that the shock wave therapy must be done by a healthcare professional trained in the technique.

The results are encouraging, agrees David G. Armstrong, DPM, MD, PhD, professor of surgery and co-director of the Southwestern Academic Limb Salvage Alliance at the University of Southern California Keck School of Medicine. He also reviewed the data on the new device. The 44% wound closure rate at 24 weeks, he says, is ''certainly in line with other active treatment modalities for foot wounds."

The shock wave therapy may be useful for smaller wounds, he says, such as the 2.5-inch wounds the new system is approved to treat. That size, he says, is typical of foot wounds.

Dr. Pandit has no disclosures and Dr. Armstrong has no relevant financial disclosures.


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