Expired Study
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Houston, Texas 77030


Purpose:

This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.


Study summary:

PAOD results in a decrease in arterial blood flow to the lower limb and feet with symptoms that can include, pain at rest, a numbing sensation in limb or feet, limited ability to walk before pain occurs. PAOD can occur along with diabetic ulcers. Proposed treatment will be given at a medical center with an overnight hospital stay. Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug (Liprostin) a special formulation of liposomal Prostaglandin E1,or PGE1, a natural occuring vasoactive hormone). Drug treatment is given twice to each artery to be treated, just before and after angioplasty. When angioplasty procedure is completed, a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure. A total of 12 PAOD subjects will be enrolled in a single center: Memorial Hermann Hospital, Houston, TX. Study will begin in February, 2003 with the last (12th) subject to be enrolled, likely by August, 20


Criteria:

Inclusion Criteria: - Male or female subjects, 18 years and older - Diagnosis of Peripheral Arterial Occlusive Disease [PAOD] - Subject is a candidate for immediate angioplasty of the lower limb - Subject must complete 2 treadmill tests at Screen in which walking distance is limited by PAOD and not due to angina or fatigue Exclusion Criteria: - Lower limb peripheral re-vascularization procedures in past 3 months - History of myocardial infarction in the past 6 months - Malignant disease, uncontrolled hypertension or Class III heart failure - Aortic occlusion, thrombosed popliteal aneurysm, severe hemorrhagic disorder, or a long iliac occlusion


NCT ID:

NCT00053716


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Catey Carter, RN
Phone: 713-500-6550
Email: catharine.v.carter@uth.tmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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