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Gene Therapy Trial Focuses on Leg Pain

The treatment could improve circulation without surgery, researchers hope

FRIDAY, April 29, 2005 (HealthDay News) -- A major new clinical trial could offer hope to patients with a common cause of disabling leg pain.

Severe intermittent claudication causes serious pain in the legs during walking and exercise. The condition occurs in people who have narrowing of the arteries and resulting poor circulation, which causes pain in the limbs and can also hinder wound healing.

The new trial, involving 300 patients at 35 sites worldwide, will determine whether injecting an engineered form of a human gene into patients' legs can help the body create new blood vessels at these sites. This new vessel growth might help improve leg circulation and help patients avoid the need for surgery.

"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 [blockage]," researcher Dr. Catherine Wittgen, an associate professor of surgery at Saint Louis University School of Medicine, said in a prepared statement.

"While gene therapy is being extensively studied for a number of diseases, this is the first large clinical trial for patients with claudication," she said.

"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 explained. "We are hoping this investigational gene treatment will be an effective but less invasive alternative therapy for some of them."

More information

The American Academy of Family Physicians has more about claudication.

SOURCE: Saint Louis University, news release, April 8, 2005
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