UT-15C SR in the Treatment of Critical Limb Ischemia
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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