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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Reduction in the proportion of subjects who experience a major amputation.
Reduction in proportion of subjects who die within 6 months from treatment initiation.
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.
Improvement in quality of life.
Improvement in hemodynamic measurements.
Improvement in neuropathy.
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Unnamed facility
Glendale, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Pensacola, Florida, United States
Unnamed facility
Springfield, Illinois, United States
Unnamed facility
Shawnee Mission, Kansas, United States
Unnamed facility
Kenner, Louisiana, United States
Unnamed facility
Royal Oak, Michigan, United States
...and 12 more locations