Trial Information

Summary: SIMPADICO: Protocol 0101

We are conducting a clinical research study to evaluate the effectiveness and safety of a novel therapy in patients with blocked arteries in the legs. The purpose of this research is to evaluate whether this new treatment will improve your ability to walk without discomfort. It has been studied in more than 400 patients thus far, including approximately 120 patients with blocked arteries in the legs.

A total of 500 patients at 60 medical centers in the United States and Canada will be asked to participate in this study. Mount Sinai Hospital expects to enroll at least 20 individuals in the study. Studies in Europe suggest that this type of therapy may be helpful in increasing walking distance and decreasing pain in patients with blocked arteries in their legs.

All procedures related to this study will be at no cost to you or your insurance.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

1. Age >40 years old
2. History of Intermittent Claudication (pain in legs) due to peripheral arterial disease
3. Walking distance limited by intermittent claudication

1. Women who are pregnant, lactating, or of childbearing potential not using accepted contraceptive methods.
2. Hepatitis, HIV, AIDS, serious active infections, gastrointestinal tract bleeding.
3. Gangrene
4. Buerger's disease
5. Malignancy within five years prior to screening. Patients with basal cell carcinoma or carcinoma insitu of the cervix will not be excluded.
6. Organ transplant
7. Allergy to sodium citrate, or any &qout;caine&qout; type of local anesthetic.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.