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
560
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Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Reduction in 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.
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
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Los Angeles, California, United States
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Pasadena, California, United States
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San Francisco, California, United States
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Pensacola, Florida, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
Unnamed facility
New Orleans, Louisiana, United States
...and 17 more locations