NCT00060996

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

May 19, 2003

Last Update Submit

March 5, 2013

Conditions

Critical Limb IschemiaPeripheral Vascular DiseaseFoot UlcersRest Leg Pain

Keywords

Critical Limb IschemiaPeripheral Vascular DiseaseUT-15Remodulintreprostinil

Interventions

Remodulin® (treprostinil sodium) InjectionDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

University of South Florida College of Medicine

Tampa, Florida, 33606, United States

Location

University of Massachusetts Memorial Health

Worcester, Massachusetts, 01655, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407-1139, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Presbyterian Medical Center, Philadelphia Heart Institute

Philadelphia, Pennsylvania, 19104, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaPeripheral Vascular DiseasesFoot Ulcer

Interventions

treprostinilInjections

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemiaFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Michael Wade, PhD

    United Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2003

First Posted

May 20, 2003

Study Start

February 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(7)