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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Peripheral Arterial Occlusive Disease

Trial Information

NO PAIN Study: a double blind, placebo-controlled study of L-arginine in the treatment of peripheral arterial disease

Study Description:

You are invited to participate in this study because you have restricted blood flow to your legs caused by disease in the leg arteries. An insufficient blood supply to the leg is the cause of leg pain while walking, and sometimes chronic pain or painful ulcers. This study is being done to see if L-arginine can safely treat your leg pain by improving blood flow. L-arginine is a substance (an amino acid) normally present in the body. In human studies it has been shown to restore blood flow to the leg, which suffers from insufficient blood supply due to blood vessel blockages. The effectiveness and safety of L-arginine will be evaluated in patients who have various degrees of leg pain secondary to blockages in blood vessels caused by atherosclerotic disease (hardening of the arteries). The study period covers approximately 6 months and will include between 6 and 12 visits. The National Institute of Health is providing financial support for this study, which will include 130 patients.

Study Criteria:

• Patients should be over age 40
• Patients need to be able to do a treadmill
• They cannot have had cancer for 5 years
• Cannot be on dialysis
• Cannot have had a heart attack 3 months prior to the study
• Cannot have Rheumatoid arthritis
• Cannot be taking Pentoxifilline (Trental) or Cilostazol (Pletal) or the supplements L-arginine (aside from the study supplements), L-carnitine, or Gingko biloba during the study period because they may interfere with the effects of our nutritional intervention. You need to be off any of these medications or supplements for 1 month prior to initial testing for accuracy.

Kathi Kari or Gina Droll for Spanish speaking, Study Coordinators
Stanford University Medical Center
300 Pasteur Drive
Falk Cardiovascular Bldg.
Stanford, CA 94305-5406
Phone: 650-723-4064
Fax: 650-724-7224
EMail: nopain@cvmed.stanford.edu

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