Recruiting
Phase 2

UT-15C SR

Sponsor:

Southern Arizona Vascular Institute

Code:

NCT00445159

Conditions

Critical Limb Ischemia

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

UT-15C SR (treprostinil diethanolamine) 1mg oral tablets

Study Details

Brief 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

Conditions

Critical Limb Ischemia

Study ID

NCT00445159

Start date

Nov, 2006

Status verified date

Mar, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Interventions

UT-15C SR (treprostinil diethanolamine) 1mg oral tablets

Primary outcome measure

  • To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Southern Arizona Vascular Institute

Recruiting

Tucson, Arizona, United States, 85704

Contacts

Sonia Voigt, RN

520-297-5846svoigt@azvasc.com

Principal Investigator:

Scott S Berman, MD

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62794-9638

Contacts

Carol Buettner

217-545-2320cbuettner@siumed.edu

Principal Investigator:

Colleen Johnson, MD

More Information

Sponsor

Southern Arizona Vascular Institute

Last update posted

Mar 8, 2007

Last verified

Mar, 2007

Keywords

  • UT-15C SR, Peripheral Vascular Disease, treprostinil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern Arizona Vascular Institute on 2007-03-08.