Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft

Phase 3TerminatedNCT00067041

United Therapeutics30 enrolled

Overview

Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peripheral Vascular Disease

Interventions

Remodulin (treprostinil sodium) InjectionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

* Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Locations (4)

Southern Illinois University School of Medicine

Springfield, Illinois, United States

University of Massachusetts Memorial Health Center

Worcester, Massachusetts, United States

Vascular Institute Albany Medical College

Albany, New York, United States

Oregon Health Sciences University

Portland, Oregon, United States

Data from ClinicalTrials.gov

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