Improved Treatment for Blocked Leg Veins Studied

A method that may reduce repeat surgeries for a painful leg condition is under investigation at Baylor College of Medicine.

The condition, known as peripheral vascular disease, occurs when arteries in the leg narrow, blocking blood circulation. To bypass the blockage, surgeons commonly graft a healthy artery from the leg onto the diseased one.

"The procedure works well, but unfortunately nearly a quarter of all bypass procedures for peripheral vascular disease fail within a year and require another surgery," said Alan Lumsden, M.D. professor and chief of the vascular surgery section in the Michael E. DeBakey department of surgery at Baylor.

PVD makes walking painful, and may also cause numbness, tingling and weakness in the legs. In severe cases, patients may develop sores on the leg or foot that don’t heal, leading to gangrene, a serious condition that may require amputation.

Lumsden’s research team is analyzing whether a process called oligodeoxynucleotide (ODN) transfection will result in fewer graft failures and surgeries. ODN are small pieces of DNA that are one-thousandth the size of a typical gene. Transfection is the process of delivering this small DNA strand to the living cells in a vein graft. The study uses a drug called CGT003 that contains ODN.

"The drug slows or stops cells in the blood vessel wall from growing, which we hope will reduce the narrowing that occurs in bypass grafts," Lumsden said.

A total of 1,400 subjects at 50 institutions across the United States are participating in the Phase III randomized, multi-center study, sponsored by the biotechnology company Corgentech. Baylor plans to recruit 35 subjects who will be randomly assigned to receive a placebo graft or graft treated with the drug.

After being harvested in the usual manner from the leg, the grafts are bathed in the drug solution outside the body in a pressure device for 10 minutes and then inserted into the patient by the surgeon. Subjects will be followed for a year following the surgery to see if the graft is showing signs of failure.

For more information about the clinical trial for patients undergoing peripheral arterial bypass graft procedures, contact Debra Crawford at (713) 798-8968.

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©2006 Texas Medical Center

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