Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
TerminatedPhase 3NCT00060996
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Critical Limb Ischemia
- Peripheral Vascular Disease
- Foot Ulcers
- Rest Leg Pain
- Interventions
- Drug: Remodulin® (treprostinil sodium) Injection
- Sponsor
- United Therapeutics
- Start date
- 2003-02
- Primary completion
- 2004-09
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00060996