NCT00067041

Brief Summary

Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

August 8, 2003

Last Update Submit

March 5, 2013

Conditions

Peripheral Vascular Disease

Keywords

Critical Limb IschemiaAutogenous Bypass GraftCLI

Interventions

Remodulin (treprostinil sodium) InjectionDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

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

Sponsors & Collaborators

Study Sites (4)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

University of Massachusetts Memorial Health Center

Worcester, Massachusetts, 01655, United States

Location

Vascular Institute Albany Medical College

Albany, New York, 12208, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Peripheral Vascular DiseasesChronic Limb-Threatening Ischemia

Interventions

treprostinilInjections

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2003

First Posted

August 13, 2003

Study Start

March 1, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(4)