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Clinical Trials : Diffusion Sponsored Trial



Clinical Research Study for Patients with Intermittent Claudication

Peripheral Arterial Disease (PAD) is a narrowing of the blood vessels that supply the limbs, decreasing available blood flow and therefore decreasing the availability of oxygen in the muscle. This lack of oxygen frequently leads to walking impairment from leg pain known as intermittent claudication (IC).  IC can include cramping, aching, or fatigue in the leg muscles when walking. The IC symptoms usually improve after resting. 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. A new drug called trans sodium crocetinate (TSC) is being developed as a potential treatment for PAD.  The goal of TSC is to allow more oxygen to move into the muscles to reduce leg pain and other IC symptoms.

A clinical trial of TSC is being conducted in up to 48 PAD patients at a number of 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 visits 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 IC, among other qualifications.

For more information, investigative site locations, and a detailed list of inclusion and exclusion criteria, please click here.

This information is included for patient information only. The Vascular Disease Foundation does not endorse any clinical research studies.