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

NCT ID: NCT00059644

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2004-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vascular Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ecraprost in lipid emulsion CLI peripheral vascular amputation Critical Limb Ischemia due to peripheral arterial disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ecraprost in lipid emulsion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phoenix, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Glendale, California, United States

Site Status

Los Angeles, California, United States

Site Status

Pasadena, California, United States

Site Status

San Francisco, California, United States

Site Status

Pensacola, Florida, United States

Site Status

Springfield, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Royal Oak, Michigan, United States

Site Status

Biloxi, Mississippi, United States

Site Status

Kansas City, Missouri, United States

Site Status

Henderson, Nevada, United States

Site Status

West Caldwell, New Jersey, United States

Site Status

New York, New York, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Portland, Oregon, United States

Site Status

San Antonio, Texas, United States

Site Status

Tacoma, Washington, United States

Site Status

Birmingham, , United Kingdom

Site Status

Bristol, , United Kingdom

Site Status

Dundee, , United Kingdom

Site Status

Hull, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Southhampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WFI 01-01

Identifier Type: -

Identifier Source: org_study_id