UT-15C SR in the Treatment of Critical Limb Ischemia

NCT00445159 | Unknown Phase 2 DMC

• 1 other identifier: UT-15C
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

UT-15C SR, Peripheral Vascular Disease, treprostinil

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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)

Interventions

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

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Arizona Vascular Institute: lead
• Southern Illinois University: collaborator

Study Sites (2)

Southern Arizona Vascular Institute

Tucson, Arizona, 85704, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9638, United States

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Colleen Johnson, MD

  Southern Illinois University

  PRINCIPAL INVESTIGATOR

• Scott S Berman, MD

  Southern Arizona Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: November 1, 2006
• Last Updated: March 8, 2007

Record last verified: 2007-03

Locations

US (2)