Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease - Tabular View

Tracking Information
First Received Date ^ICMJE	April 29, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	July 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Reduction in proportion of subjects who experience a major amputation. Reduction in proportion of subjects who die within 6 months from treatment initiation.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00059644 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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. Improvement in hemodynamic measurements. Improvement in neuropathy.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Official Title ^ICMJE	A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM for the Treatment of Critical Leg Ischemia
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Peripheral Vascular Disease
Intervention ^ICMJE	Drug: Ecraprost in lipid emulsion
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	560
Completion Date	June 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00059644
Responsible Party
Study ID Numbers ^ICMJE	WFI 01-01
Study Sponsor ^ICMJE	Mitsubishi Tanabe Pharma Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Mitsubishi Tanabe Pharma Corporation
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP