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Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
NCT00651885 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ochsner Health System, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00651885 reports 1 study location spanning 1 distinct geographic area — top geographies include Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00651885?
The interventions under investigation include: Placebo (DRUG), treprostinil dienthanolmine sustained release (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00651885?
This trial is sponsored by Ochsner Health System, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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