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

Primary Purpose

Critical Limb Ischemia

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Critical Limb Ischemia focused on measuring UT-15C SR, Peripheral Vascular Disease, treprostinil

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Southern Arizona Vascular InstituteRecruiting
Southern Illinois University School of MedicineRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

To obtain peak and trough treprostinil plasma levels in CLI subjects

Full Information

NCT ID

NCT00445159

First Posted

March 7, 2007

Last Updated

March 7, 2007

Sponsor

Southern Arizona Vascular Institute

Collaborators

Southern Illinois University

1. Study Identification

Unique Protocol Identification Number

NCT00445159

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Unknown status

Study Start Date

November 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Southern Arizona Vascular Institute

Collaborators

Southern Illinois University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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 pain, with or without an ischemic wound present. Conventional therapy should be continued without changes over the course of the study for all subjects. Group 1: The first ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability, to a maximum dose of 4mg/day . Group 2: The last ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability to a maximum dose of 8 mg/day .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Limb Ischemia

Keywords

UT-15C SR, Peripheral Vascular Disease, treprostinil

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To assess the effect of UT-15C on the following disease symptoms associated with CLI:

Title

ž Ischemic rest pain

Title

ž Sleep interference

Title

ž Ambulatory status

Title

ž Ischemic wound healing (if applicable)

Title

To obtain peak and trough treprostinil plasma levels in CLI subjects

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen Johnson, MD

Organizational Affiliation

Southern Illinois University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Scott S Berman, MD

Organizational Affiliation

Southern Arizona Vascular Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Southern Arizona Vascular Institute

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonia Voigt, RN

Phone

520-297-5846

svoigt@azvasc.com

First Name & Middle Initial & Last Name & Degree

Scott S Berman, MD

Facility Name

Southern Illinois University School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62794-9638

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carol Buettner

Phone

217-545-2320

cbuettner@siumed.edu

First Name & Middle Initial & Last Name & Degree

Colleen Johnson, MD

12. IPD Sharing Statement

Learn more about this trial

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

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