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

Completed · Phase 3

Conditions studied: Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT00059657

Run by

Tanabe Pharma Corporation

People needed

280

Starts

2001-08-01

Expected to finish

2005-11-01

Last updated by the study team

2006-05-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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
• Subjects will already be scheduled to receive a revascularization procedure (e.g., by-pass graft, endovascular procedure, etc.) involving a distal target artery below the knee joint (e.g., below the knee joint popliteal, anterior/posterior tibial, peroneal, plantar, pedal, etc.) as part of their normal standard of care.

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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Glendale, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Pensacola, Florida, United States
• Study site — Springfield, Illinois, United States
• Study site — Shawnee Mission, Kansas, United States
• Study site — Kenner, Louisiana, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Biloxi, Mississippi, United States
• Study site — Rochester, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — San Antonio, Texas, United States
• Study site — Tacoma, Washington, United States
• Study site — Birmingham, United Kingdom
• Study site — Bristol, United Kingdom
• Study site — Dundee, United Kingdom
• Study site — Hull, United Kingdom
• Study site — London, United Kingdom
• Study site — Manchester, United Kingdom
• Study site — Southhampton, United Kingdom

Full record on ClinicalTrials.gov

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