Local Inventor Offers Hope to Millions of Diabetics
Technology derived from burn victim treatment shows early promise for diabetic foot ulcers that affect 2.35 million Americans
SAN MARCOS, Calif. (August 18, 2005) — Diabetes has reached epidemic levels in the U.S. with diabetic foot ulcers affecting 1 out of 6 diabetics. Foot lesions are one of the most difficult to treat and harmful complications of diabetes – resulting in more than 50% of the lower-limb amputations that occur nationwide. A diabetic foot wound that remains unhealed after one month is associated with a poor outcome - gangrene and, ultimately, amputation.
Local inventor Adrian Pelkus has taken technology he originally conceived for treating burn victims and applied it to the development of a device that offers localized treatment of foot ulcers with remarkable results. Early trials in the Poway office of Dr. Clifford J. Wolf demonstrated that open wounds were healed within 3 weeks on patients whose open wounds had gone 6 to 12 months without responding to conventional treatment. The treatment device, MISLY™, was cleared to market by the FDA last month, and clinical trials continue in both Poway and in the Tustin office of Dr. Lyman Wilson to gain additional patient data.
If you can oxygenate and hydrate the tissue where a wound is, the tissue can regenerate faster, says Pelkus. The problem for diabetics is that they commonly suffer vascular complications that diminish the blood flow to the extremities. This limits the amount of oxygen pressure in the tissue that is needed to promote healing. MISLY™ is a hyperoxia treatment that focuses oxygen and nutrients to the damaged cells so that they can regenerate. Patients insert their foot into the box-like device, which hydrates the wound with a fine penetrating mist that alternates with an application of oxygen under slight pressure. Each in-office session lasts about one hour and costs no more than conventional in-office treatments.
Initial results have been very positive, so much so that we feel we need to continue trials, even though we’ve been FDA cleared, just to confirm that this level of success can be consistently repeated, says Pelkus. So far, the trials underway in Tustin are showing the same excellent results. Both patients have seen a significant reduction in the size of their ulcers after just three treatments, and both had wounds that were open for 12 months prior to the start of treatment with MISLY™. We plan to continue trials for the next few months and are actively looking for additional patients.
Pelkus founded IYIA Technologies, located in San Marcos, in April 2004 to develop and market the new medical device. The company name, IYIA (pronounced ay-EE-yah), is based on the Greek word for health. Pelkus is President and CEO of IYIA Technologies and is a named inventor on four issued U.S. Patents, including Fortune magazine’s Product of the Year in 1994. MISLY™ is a proprietary, patent-pending device for treating patients with slow healing foot wounds, primarily diabetic foot ulcers.
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