A Phase 2 interventional study of UT-15C SR (treprostinil diethanolamine) 1mg oral tablets in Critical Limb Ischemia, sponsored by Southern Arizona Vascular Institute. Status unknown at 2 sites in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-03-08.
Sponsored by Southern Arizona Vascular Institute · Phase 2, Interventional, and Supportive care
This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease. Rest pain is one of the primary management issues of severe arterial occlusive disease and may lead to amputation when the pain becomes intolerable and unresponsive to narcotic analgesia. Rest pain also impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased mobility. Treprostinil sodium (Remodulin®) has been studies in several small open-label studies and has been shown to be safe as well as an effective agent for ischemic rest pain when given by subcutaneous or intravenous delivery. However, these forms of administration have patient convenience limitations, including the need for an infusion device and associated pain at the site of infusion with subcutaneous delivery. UT-15C may allow patients suffering from CLI to benefit from the simplicity of an oral dosage form
This study is an eight week, two center, open-label study assessing the tolerability, safety, and efficacy of oral UT-15C sustained release tablets in subjects with CLI and ischemic lower limb rest pain, with or without an ischemic wound present. Conventional therapy should be continued without changes over the course of the study for all subjects.
Group 1: The first ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability, to a maximum dose of 4mg/day .
Group 2: The last ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability to a maximum dose of 8 mg/day .
343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 233 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →This is the only study on the registry with Southern Arizona Vascular Institute as lead sponsor.
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Exclusion Criteria:
To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain
To assess the effect of UT-15C on the following disease symptoms associated with CLI:
ž Ischemic rest pain
ž Sleep interference
ž Ambulatory status
ž Ischemic wound healing (if applicable)
To obtain peak and trough treprostinil plasma levels in CLI subjects
This study is status unknown, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia→