Newswise — Saint Louis University researchers have begun testing an investigational treatment for severe intermittent claudication, a common condition that causes disabling pain in the legs during walking and exercise.
Claudication occurs in patients who have atherosclerosis—arteries clogged by deposits of plaque. The resulting poor circulation causes pain to develop in the limbs and can impair wound healing.
Researchers in a new clinical trial hope that by injecting an engineered form of a human gene into a patient's legs they can help the patient's own body to create new blood vessels in the legs and increase circulation without surgery or angioplasty.
Catherine Wittgen, M.D., associate professor of surgery at Saint Louis University School of Medicine, is the Saint Louis University principal investigator for the trial, which will enroll 300 patients at 35 sites worldwide.
"We are trying to activate a gene already naturally present in the body, which will cause the body to make new unobstructed blood vessels around places of occlusion," she said. "While gene therapy is being extensively studied for a number of diseases, this is the first large clinical trial for patients with claudication."
Left untreated, claudication severely limits a patient's ability to perform normal activities such as walking through the grocery story or mowing the lawn, and it can ultimately require amputation in patients who have wounds that do not heal due to lack of circulation.
Current studies estimate that as many as 20 percent of men and 15 percent of women over the age of 60 suffer from some type of peripheral arterial disease " diseases caused by poor circulation due to atherosclerosis— including claudication. Diabetes, smoking and high blood pressure are all risk factors for the development of peripheral arterial disease.
"Surgeries and angioplasty with stenting are treatment options for patients who have peripheral artery disease and need to get more blood circulating in their legs so they can walk further or have wounds heal," Wittgen said.
"We are hoping this investigational gene treatment will be an effective but less invasive alternative therapy for some of them."
A smaller prior study of this treatment, which was developed by the Genzyme Corporation, found it did not cause serious side effects in patients with critical limb ischemia, a more severe form of peripheral arterial disease.
For more information about enrolling in the trial at the Saint Louis University site, call (314) 977-6335.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.
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