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NCT00651885 · ClinicalTrials.gov registry record · Phase 2
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
A Phase 2 study of Critical Limb Ischemia, sponsored by Ochsner Health System.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT00651885: Completed Phase 2 study of Critical Limb Ischemia, sponsored by Ochsner Health System.
NCT00651885 is a Phase 2 study of Critical Limb Ischemia that has completed, run by Ochsner Health System. The registered enrollment target is 7 participants, below the 91-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00651885, a Phase 2 study of Critical Limb Ischemia, has completed, sponsored by Ochsner Health System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as percutaneous transluminal endovascular intervention, as well as reconstructive surgical procedures such as grafts or bypasses. Amputation is a last resort where limb salvage cannot be achieved. Despite the success of percutaneous intervention for small coronary vessels with lumen diameters less than 3 mm, similar techniques have had limited success in the lower extremity vessels. Infra-popliteal, or below the knee endovascular intervention, is commonly plagued by subacute thrombotic closure and restenosis in as many as 50% of treated patients. As a result of the limited success, these percutaneous procedures have been reserved for the severest cases whereby limb loss is imminent without intervention. In this context, the sickest of all patients are enrolled in these trials and poor outcomes are common regardless of the intervention. Agents that promote intracellular cAMP accumulation, including prostacyclin analogues and phosphodiesterase inhibitors, suppress smooth muscle proliferation, promote vasodilatation and inhibit platelet aggregation. These properties suggest that prostacyclin analogues such as treprostinil will be useful adjuncts to peripheral endovascular intervention and perhaps increase the number of patients with CLI that can benefit from peripheral endovascular intervention. An orally available prostacyclin analogue could represent an important treatment advance in the prevention of restenosis following infrapopliteal angioplasty. In the present study, the safety and efficacy of oral UT-15C sustained release (SR) tablets will be compared to placebo in patients with CLI undergoing an infra-popliteal endovascular intervention.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG treprostinil dienthanolmine sustained release
Study Locations (1)
Louisiana
- Ochsner Clinic Foundation - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00651885
The ClinicalTrials.gov registry entry for NCT00651885 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (92% lower). The listed sponsor is Ochsner Health System, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Critical Limb Ischemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00651885 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT00651885 about?
NCT00651885 is a clinical study titled "Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure". In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as percutaneous transluminal endovascular intervention, as well as reconstru...
What is the current status of trial NCT00651885?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2008-03. Estimated completion is 2010-12.
What conditions does trial NCT00651885 study?
This clinical trial studies the following conditions: Critical Limb Ischemia.
What interventions are being tested in trial NCT00651885?
The interventions under investigation include: Placebo (DRUG), treprostinil dienthanolmine sustained release (DRUG).
Who is sponsoring clinical trial NCT00651885?
This trial is sponsored by Ochsner Health System, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00651885 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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