Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial 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: NCT00059657|
Recruitment Status : Completed
First Posted : May 2, 2003
Last Update Posted : May 19, 2006
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease||Drug: Ecraprost in lipid emulsion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM in Conjunction With Peripheral Revascularization for the Treatment of Critical Leg Ischemia|
|Study Start Date :||August 2001|
|Study Completion Date :||November 2005|
- Reduction in the proportion of subjects who experience a major amputation.
- Reduction in proportion of subjects who die within 6 months from treatment initiation.
- Reduction in major amputation rate only.
- Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)
- Improvement in graft patency of index operation.
- Improvement in complete ulcer healing.
- Improvement in pain at rest.
- Improvement in quality of life.
- Improvement in hemodynamic measurements.
- Improvement in neuropathy.
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): NCT00059657
|United States, Arizona|
|Phoenix, Arizona, United States|
|Tucson, Arizona, United States|
|United States, California|
|Glendale, California, United States|
|Los Angeles, California, United States|
|San Francisco, California, United States|
|United States, Florida|
|Pensacola, Florida, United States|
|United States, Illinois|
|Springfield, Illinois, United States|
|United States, Kansas|
|Shawnee Mission, Kansas, United States|
|United States, Louisiana|
|Kenner, Louisiana, United States|
|United States, Michigan|
|Royal Oak, Michigan, United States|
|United States, Mississippi|
|Biloxi, Mississippi, United States|
|United States, New York|
|Rochester, New York, United States|
|United States, North Carolina|
|Durham, North Carolina, United States|
|United States, Texas|
|San Antonio, Texas, United States|
|United States, Washington|
|Tacoma, Washington, United States|
|Birmingham, United Kingdom|
|Bristol, United Kingdom|
|Dundee, United Kingdom|
|Hull, United Kingdom|
|London, United Kingdom|
|Manchester, United Kingdom|
|Southhampton, United Kingdom|