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

NCT ID: NCT00060996

Last Updated: 2013-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Limb Ischemia Peripheral Vascular Disease Foot Ulcers Rest Leg Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Remodulin® (treprostinil sodium) Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Wade, PhD

Role: STUDY_DIRECTOR

United Therapeutics

Locations

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University of South Florida College of Medicine

Tampa, Florida, United States

Site Status

University of Massachusetts Memorial Health

Worcester, Massachusetts, United States

Site Status

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Presbyterian Medical Center, Philadelphia Heart Institute

Philadelphia, Pennsylvania, United States

Site Status

South Carolina Heart Center

Columbia, South Carolina, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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REM 03:202

Identifier Type: -

Identifier Source: org_study_id

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