If You Have PAD, Your Help Is Needed!

People with peripheral arterial disease (PAD) are urgently needed to help with two important clinical trials. These trials will help determine what treatments work best. Both of these trials seek to identify people who have "intermittent claudication," which is usually experienced as thigh or calf muscle pain that occurs with walking and that always goes away with rest.

1. The CLEVER Study (Claudication: Exercise Versus Endoluminal Revascularization) is a clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. Potential participants must have PAD and experience claudication symptoms. This study is comparing the effectiveness of exercise therapy versus endovascular treatment (stent placement) of aortoiliac disease.

If you live in one of the states or province listed below and want more information, visit www.cleverstudy.org or call toll-free 1-877-534-0533.

Arkansas		Maine		Nova Scotia
California		Maryland		Ohio
Florida		Michigan		Oregon
Illinois		Minnesota		Pennsylvania
Iowa		New York		Rhode Island
Louisiana		North Carolina		Washington
				West Virginia

2. A new drug called trans sodium crocetinate (TSC) is being evaluated as a potential treatment for PAD. The limited availability of oxygen in the muscle associated with PAD frequently leads to intermittent claudication. Insufficient movement of oxygen through the blood to the muscle could be part of the reason for the overall shortage of oxygen in the leg muscles. This study will test the potential benefits and risks of TSC, as this compound is thought to allow more oxygen to move into the muscles to reduce claudication symptoms.

A clinical trial of TSC is being conducted in up to 48 PAD patients at hospitals and clinics in the United States. Participants selected to participate in the study will receive an intravenous injection of either TSC or placebo once daily for five consecutive days. Evaluations to be performed during the trial include exercise treadmill tests, blood samples and safety measurements.

Follow-up assessments will occur at 5, 14 and 30 days after the last dose.

Participants must be aged 40 years or older and have a 6-month history of walking limitation or symptoms of claudication among other qualifications. If you live near the study locations listed below, please see trial number NCT00725881 on www.clinicaltrials.gov for contact information.

• Birmingham, Alabama
• Santa Rosa, California
• Stanford, California
• Pensacola, Florida
• Oklahoma City, Oklahoma
• Philadelphia, Pennsylvania
• San Antonio, Texas

Clinical trials are scientific research studies to evaluate new medications or treatments in human volunteers. The purpose of a clinical trial is to find out whether the treatment is safe and effective. In an ongoing effort to provide the most current information about the treatment and prognosis of vascular disease, VDF lists important clinical trials that may lead to advances in the care of, and eventually the cure for, vascular disease.

The Vascular Disease Foundation and any sponsors disclaim, either explicitly or implicitly, that any of the medications, treatments or devices listed here is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. Additionally, no claims are made regarding the scientific utility and conduct of clinical trials or research studies listed. VDF provides information about clinical trials as a public service and does not specifically endorse any of the trials listed. Consumers should thoroughly read consent forms and consult with their physicians before enrolling in any trial.

More information about clinical trials may be found at www.clinicaltrials.gov. New enrollment information for the ATTRACT trial for DVT and the BRIDGE trial will be listed soon on the clinical trial section of the VDF Web site (www.vdf.org/clinical/).

Visit it often to see other trials that are listed. You can help scientists determine better treatments for people with PAD by calling these programs to see if you can help.

VDF RECEIVES GRANT WORTH OVER $1,000,000 FROM CENTERS FROM DISEASE CONTROL AND PREVENTION (CDC)!
VDF and the Venous Disease Coalition have been awarded a grant from the CDC to promote the health of people with clotting disorders. The cooperative agreement will run for the next five years, and will involve development, implementation and evaluation of a public education program directed to women who suffer from venous thromboembolism. Women not only suffer from VTE, but also make more than 75 percent of the health-care decisions in the United States.

During the first year, the program will focus on general awareness of VTE among women, including the increased incidence of VTE in women during pregnancy and postpartum. The VDC will work with CDC and member organizations such as Spirit of Women. The prevalence of VTE in patients undergoing major surgery or suffering trauma will also be an area of focus. The increased risk of VTE in patients with cancer as well as those undergoing cancer therapies will also be featured.