NCT00059657

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

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2001

Typical duration for phase_3

Geographic Reach
2 countries

22 active sites

Status
completed

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

August 1, 2001

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

May 19, 2006

Status Verified

May 1, 2006

First QC Date

April 29, 2003

Last Update Submit

May 17, 2006

Conditions

Peripheral Vascular Disease

Keywords

Ecraprost in lipid emulsionCLIperipheral, vascularamputationAngioplastyby-passCritical Limb Ischemia due to peripheral arterial disease

Outcome Measures

Primary Outcomes (2)

  • Reduction in the proportion of subjects who experience a major amputation.

  • Reduction in proportion of subjects who die within 6 months from treatment initiation.

Secondary Outcomes (8)

  • Reduction in major amputation rate only.

  • Reduction in critical cardiovascular events (MI, stroke, CV death, etc.)

  • Improvement in graft patency of index operation.

  • Improvement in complete ulcer healing.

  • Improvement in pain at rest.

  • +3 more secondary outcomes

Interventions

Ecraprost in lipid emulsionDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Glendale, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Pensacola, Florida, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Shawnee Mission, Kansas, United States

Location

Unknown Facility

Kenner, Louisiana, United States

Location

Unknown Facility

Royal Oak, Michigan, United States

Location

Unknown Facility

Biloxi, Mississippi, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Bristol, United Kingdom

Location

Unknown Facility

Dundee, United Kingdom

Location

Unknown Facility

Hull, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Southhampton, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Ecraprost

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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

August 1, 2001

Study Completion

November 1, 2005

Last Updated

May 19, 2006

Record last verified: 2006-05

Locations

US(15)GB(7)