Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00053716|
Recruitment Status : Unknown
Verified March 2004 by Endovasc.
Recruitment status was: Recruiting
First Posted : February 6, 2003
Last Update Posted : March 7, 2007
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease||Drug: Liprostin [liposomal Prostaglandin E1]||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy With Lower Limb Angioplasty in Patients With Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease|
|Study Start Date :||February 2003|
|Study Completion Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053716
|United States, Texas|
|Memorial Hermann Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Catey Carter, RN 713-500-6550 firstname.lastname@example.org|
|Contact: Carol J Underwood, RN 713-500-6563 email@example.com|
|Principal Investigator: Richard W. Smalling, M.D., Ph.D|