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

Phase 3

Terminated

• Conditions: Peripheral Vascular Disease; Foot Ulcers; Rest Leg Pain; Critical Limb Ischemia

• Registration Number: NCT00060996
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-05-19
• Study First Submitted QC: 2003-05-19
• Study First Posted: 2003-05-20
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (7)

South Carolina Heart Center; 🇺🇸 Columbia, South Carolina, 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

University of South Florida College of Medicine; 🇺🇸 Tampa, Florida, United States

Presbyterian Medical Center, Philadelphia Heart Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States