Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

Phase 3TerminatedNCT00060996

United Therapeutics30 enrolled

Overview

The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Critical Limb Ischemia Peripheral Vascular Disease Foot Ulcers Rest Leg Pain

Interventions

Remodulin® (treprostinil sodium) InjectionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Locations (7)

University of South Florida College of Medicine

Tampa, Florida, United States

University of Massachusetts Memorial Health

Worcester, Massachusetts, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Oregon Health Sciences University

Portland, Oregon, United States

Data from ClinicalTrials.gov

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