Critical Limb IschemiaPhase 2NCT00445159
UT-15C SR in the Treatment of Critical Limb Ischemia
A Phase 2 study testing UT-15C SR (treprostinil diethanolamine) 1mg oral tablets in people with Critical Limb Ischemia, run by Southern Arizona Vascular Institute at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- UT-15C SR (treprostinil diethanolamine) 1mg oral tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9638
Carol Buettner, 217-545-2320, cbuettner@siumed.edu
Colleen Johnson, MD
- Recruiting
Southern Arizona Vascular Institute
Tucson, Arizona, 85704
Sonia Voigt, RN, 520-297-5846, svoigt@azvasc.com
Scott S Berman, MD
About this study
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
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
Read the 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 .
- Conditions
- Critical Limb Ischemia
- Being tested
- UT-15C SR (treprostinil diethanolamine) 1mg oral tablets
- Keywords
- UT-15C SR, Peripheral Vascular Disease, treprostinil
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UT-15C SR (treprostinil diethanolamine) 1mg oral tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
To obtain peak and trough treprostinil plasma levels in CLI subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Southern Arizona Vascular Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Illinois University
- Investigators
- Colleen Johnson, MD, Principal investigator, Southern Illinois UniversityScott S Berman, MD, Principal investigator, Southern Arizona Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445159
- Sponsor's protocol ID
- UT-15C
- Status last verified
- Mar 2007
- First submitted
- 7 Mar 2007
- Last updated
- 8 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00445159
- Acronym / sponsor ID
- UT-15C
- Conditions
- Critical Limb Ischemia
- Keywords
- UT-15C SR, Peripheral Vascular Disease, treprostinil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Southern Arizona Vascular InstituteUniversity, hospital or other
- Collaborators
- Southern Illinois University
- Study start
- Nov 2006
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UT-15C SR (treprostinil diethanolamine) 1mg oral tablets | Drug | – |
Primary outcome
To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Southern Illinois University School of Medicine
Springfield, United States
Colleen Johnson, MD principal investigator
Southern Illinois University
Scott S Berman, MD principal investigator
Southern Arizona Vascular Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UT-15C SR (treprostinil diethanolamine) 1mg oral tablets in people with Critical Limb Ischemia, run by Southern Arizona Vascular Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2007.