Clinical trial NCT00059644: Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM for the Treatment of Critical Leg Ischemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Peripheral Vascular Disease
Keywords: Ecraprost in lipid emulsion
CLI
peripheral
vascular
amputation
Critical Limb Ischemia due to peripheral arterial disease
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2003-05-02
Enrollment: 560
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in proportion of subjects who experience a major amputation.
measure: Reduction in proportion of subjects who die within 6 months from treatment initiation.
Secondary outcomes:
measure: Reduction in major amputation rate only.
measure: Reduction in critical cardiovascular events.
measure: Improvement in complete ulcer healing.
measure: Improvement in pain at rest.
measure: Improvement in quality of life.
measure: Improvement in hemodynamic measurements.
measure: Improvement in neuropathy.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Pensacola
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Royal Oak
country: United States
state: Michigan
city: Biloxi
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: West Caldwell
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: San Antonio
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Dundee
country: United Kingdom
city: Hull
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Southhampton
country: United Kingdom
Study officials:
References: