Back to resultsStudy of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
Primary Purpose
Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Remodulin® (treprostinil sodium) Injection
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Critical Limb Ischemia, Peripheral Vascular Disease, UT-15, Remodulin, treprostinil
Eligibility Criteria
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
Sites / Locations
- University of South Florida College of Medicine
- University of Massachusetts Memorial Health
- Minneapolis Heart Institute
- Oregon Health Sciences University
- Presbyterian Medical Center, Philadelphia Heart Institute
- South Carolina Heart Center
- The Methodist Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00060996
Brief Title
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
Keywords
Critical Limb Ischemia, Peripheral Vascular Disease, UT-15, Remodulin, treprostinil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Remodulin® (treprostinil sodium) Injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wade, PhD
Organizational Affiliation
United Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of South Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of Massachusetts Memorial Health
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407-1139
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Presbyterian Medical Center, Philadelphia Heart Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
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