UT-15C SR in the Treatment of Critical Limb Ischemia
Unknown statusPhase 2NCT00445159
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)
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
Study details
- Official title
- An Investigator Initiated Eight Week Two Center Open-Label Pilot Study of the Tolerability and Safety of Oral UT-15C (Treprostinil Diethanolamine)SR Tablets in Patients With Critical Limb Ischemia (CLI) and Ischemic Rest Pain
- Conditions
- Interventions
- Drug: UT-15C SR (treprostinil diethanolamine) 1mg oral tablets
- Sponsor
- Southern Arizona Vascular Institute
- Collaborators
- Southern Illinois University
- Start date
- 2006-11
- Sex
- All
- Age range
- from 45 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Have an ankle systolic pressure ≤ 60 mm/Hg OR ABI ≤ 0.60 OR toe systolic pressure ≤ 60 mm/Hg OR an arteriogram showing at least one level of occlusion of lower extremity arteries. 2. Have been taking analgesics to control ischemic rest pain for at least two weeks at Baseline. 3. Have signed an appropriate consent for participation in this study. 4. If female, be physiologically incapable of childbearing or practicing acceptable methods of birth c Exclusion Criteria: 1. Have had a vascular surgery or other vascular procedure to treat their CLI within 30 days prior to study entry. 2. Have a planned or scheduled vascular surgery or endovascular procedure. 3. Be currently taking any investigational drugs for CLI. 4. Have received prostaglandins such as PGE1, epoprostenol (Flolan®), or any other prostacyclin (PGI2) or prostacyclin analog in the past 30 days. 5. Be hemodynamically unstable or have acute renal failure, cardiac failure or pulmonary failure. 6. Have a diagnosis of Stage IVb (Fontaine) or Stage 6 (Rutherford scale) Critical Limb Ischemia due to documented peripheral arterial disease 7. Have an unhealed incision(s) from a toe or transmetatarsal amputation at Baseline. 8. Have any wound with significant gangrene or exposed tendons.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00445159