Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM for the Treatment of Critical Leg Ischemia
1 other identifier
interventional
560
2 countries
27
Brief Summary
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD). This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2001
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 29, 2003
CompletedFirst Posted
Study publicly available on registry
May 2, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedJune 24, 2005
June 1, 2005
April 29, 2003
June 23, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction in proportion of subjects who experience a major amputation.
Reduction in proportion of subjects who die within 6 months from treatment initiation.
Secondary Outcomes (7)
Reduction in major amputation rate only.
Reduction in critical cardiovascular events.
Improvement in complete ulcer healing.
Improvement in pain at rest.
Improvement in quality of life.
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2
- The subject has exhausted all standard revascularization treatment options at this time.
You may not qualify if:
- Subjects with a previous major amputation (at or above ankle)
- Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of \< 20 cc/min, or receiving chronic hemodialysis therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Pensacola, Florida, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Biloxi, Mississippi, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Henderson, Nevada, United States
Unknown Facility
West Caldwell, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Bristol, United Kingdom
Unknown Facility
Dundee, United Kingdom
Unknown Facility
Hull, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Southhampton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 29, 2003
First Posted
May 2, 2003
Study Start
July 1, 2001
Study Completion
June 1, 2004
Last Updated
June 24, 2005
Record last verified: 2005-06