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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060996
Recruitment Status : Terminated
First Posted : May 20, 2003
Last Update Posted : March 7, 2013
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Vascular Disease Foot Ulcers Rest Leg Pain Drug: Remodulin® (treprostinil sodium) Injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Continuous or Daily Administration of Remodulin® (Treprostinil Sodium) Injection in Patients With CLI With No Planned Revascularization Procedures
Study Start Date : February 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060996

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United States, Florida
University of South Florida College of Medicine
Tampa, Florida, United States, 33606
United States, Massachusetts
University of Massachusetts Memorial Health
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407-1139
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Presbyterian Medical Center, Philadelphia Heart Institute
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
South Carolina Heart Center
Columbia, South Carolina, United States, 29204
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
United Therapeutics
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Study Director: Michael Wade, PhD United Therapeutics

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Responsible Party: United Therapeutics Identifier: NCT00060996    
Other Study ID Numbers: REM 03:202
First Posted: May 20, 2003    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013
Keywords provided by United Therapeutics:
Critical Limb Ischemia
Peripheral Vascular Disease
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Cardiovascular Diseases
Arterial Occlusive Diseases
Antihypertensive Agents