Med Device Monday: A Device to Treat Diabetic Foot Ulcers

Type 2 Diabetes—also known as adult-onset diabetes—is a chronic condition that affects the way the body metabolizes sugar. Blood sugar levels increase because the body does not either make or use insulin well. Insulin is the hormone that helps get sugar into cells to give them energy. Chronic diabetes can result in complications such as cardiovascular disease, nerve damage (neuropathy), kidney damage (nephropathy), eye damage (retinopathy), and foot damage.

Nerve damage in the feet, or poor blood flow to the feet, increases the risk of various complications like foot ulcers. Left untreated, cuts and blisters can develop serious infections, which often heal poorly. These infections may ultimately require toe, foot, or leg amputation. Diabetes is the leading cause of nontraumatic lower extremity amputations in the United States, with approximately 5% of diabetics developing foot ulcers each year and 1% requiring amputation.

FDA recently approved a device called dermaPACE®, developed by SANUWAVE Health, Inc., dermaPACE® is intended to be used in the treatment of chronic, full-thickness (meaning through all dermis layers), diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top). dermaPACE® is an external shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. 

 Photo from sanuwave.com.

Photo from sanuwave.com.

According to SANUWAVE Health Inc., this Pulsed Acoustic Cellular Expression (PACE) technology utilizes high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to elicit a series of biological responses. PACE treatment results in increased circulation, and—to get technical—biofilm disruption, cytokine and chemokine effects, growth factor upregulation, and angiogenesis (new blood vessel formation). In other words, many of the factors that lead to the subsequent regeneration of tissue such as skin, musculoskeletal, and vascular structures. In other words: healing.

See it in action (while this is an animation, some images are not for the faint of heart):

Results of a clinical trial showed that in a total of 336 diabetic patients receiving either usual care, including wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus dermaPACE® shock wave therapy or usual care plus placebo shock wave therapy, there was 44 percent wound closure rate in patients treated with dermaPACE®, as compared to 30 percent wound closure rate in patients treated with the placebo shock wave therapy.

dermaPACE® has also received the European CE Mark approval to treat diabetic foot ulcers and is actively marketed in Europe, Canada and Asia.

While a cure for diabetes is still being pursued, it's certainly a positive to see new devices come to market to mitigate and treat side effects of the disease. 

 

Further Reading

FDA press release on Dermapace

dermaPACE® by Sanuwave