Growing blood vessels around clots in leg arteries may treat painf...( g coordinated by the Duke Clinical Rese...),Health

Patients with clogged blood vessels in their legs suffer from what is known as peripheral artery disease. This chronic, progressive condition is similar to heart disease in that arteries become obstructed with a buildup of plaque. This results in a dearth of oxygen to leg muscles, which causes pain or "claudication" - the same process by which an oxygen-starved heart produces angina.

"It's a straightforward supply-and-demand problem," Annex said. "Walking increases the demand for oxygen in leg muscles, so walking is painful. This discomfort only gets better with rest."

Some patients can be treated with leg by-pass surgery or angioplasty, a procedure that flattens plaque inside the artery, but for many, the disease is too extensive for such options. Those are the kind of patients participating in this trial, Annex said. "There are lots of branches in a leg artery, which can have multiple blockages. The trial is designed to help a group of patients who cannot readily be treated in other ways."

The drug being tested is a recombinant protein made in bacteria that is nearly identical to one produced naturally in humans. While investigators don't know how it works in the body, in a test tube Annex said the protein "is a potent angiogenic agent that promotes the grow of endothelial or blood vessel cells." He theorizes that a dose delivered into the top of the leg artery (the femoral artery near the hipbone) flows down through blood vessels to the place or places where clogs exist. "The agent could be going to the muscle that is starved for oxygen to help produce new vessels around the blockage or it could be making collateral vessels that already exist work better. We just don't know."

Patients enrolled in the study will be followed for six months to measure changes in their capacity to exercise and their quality of life.

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Contact: Renee Twombly
Twomb001@mc.duke.edu
919-684-4148
Duke University Medical Center
9-Jan-2000