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

NCT00060996 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-03-07

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Remodulin® (treprostinil sodium) Injection

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Michael Wade, PhD · United Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2004-09-30
Completion
2004-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00060996 on ClinicalTrials.gov