Status:
UNKNOWN
UT-15C SR in the Treatment of Critical Limb Ischemia
Lead Sponsor:
Southern Arizona Vascular Institute
Collaborating Sponsors:
Southern Illinois University
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
45-85 years
Phase:
PHASE2
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 manage...
Detailed Description
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 pa...
Eligibility Criteria
Inclusion
- 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.
- Have been taking analgesics to control ischemic rest pain for at least two weeks at Baseline.
- Have signed an appropriate consent for participation in this study.
- If female, be physiologically incapable of childbearing or practicing acceptable methods of birth c
Exclusion
- Have had a vascular surgery or other vascular procedure to treat their CLI within 30 days prior to study entry.
- Have a planned or scheduled vascular surgery or endovascular procedure.
- Be currently taking any investigational drugs for CLI.
- Have received prostaglandins such as PGE1, epoprostenol (Flolan®), or any other prostacyclin (PGI2) or prostacyclin analog in the past 30 days.
- Be hemodynamically unstable or have acute renal failure, cardiac failure or pulmonary failure.
- Have a diagnosis of Stage IVb (Fontaine) or Stage 6 (Rutherford scale) Critical Limb Ischemia due to documented peripheral arterial disease
- Have an unhealed incision(s) from a toe or transmetatarsal amputation at Baseline.
- Have any wound with significant gangrene or exposed tendons.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00445159
Start Date
November 1 2006
Last Update
March 8 2007
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern Arizona Vascular Institute
Tucson, Arizona, United States, 85704
2
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9638