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Prostaglandin
UT-15C SR for Critical Limb Ischemia
Phase 2
Waitlist Available
Led By Colleen Johnson, MD
Research Sponsored by Southern Arizona Vascular Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
If female, be physiologically incapable of childbearing or practicing acceptable methods of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will evaluate if UT-15C, a sustained release tablet, is an effective and safe agent for ischemic lower limb rest pain related to advanced peripheral arterial disease.
Who is the study for?
This trial is for individuals with severe blockages in the arteries of their lower limbs, causing pain at rest. Participants must have specific low blood pressure measurements in their ankles or toes, or an arteriogram showing occlusion. They should be on painkillers for at least two weeks and not pregnant or agree to use birth control. Exclusions include recent vascular procedures, investigational drug use for CLI, planned surgeries, certain prostaglandin treatments within 30 days, hemodynamic instability, advanced critical limb ischemia stages, unhealed amputation incisions, or significant gangrene.Check my eligibility
What is being tested?
The study tests UT-15C sustained release tablets as a potential treatment for ischemic rest pain due to advanced peripheral arterial disease. It aims to provide relief from severe limb pain that disrupts sleep and mobility without the inconvenience of infusion devices required by similar drugs like Remodulin®.See study design
What are the potential side effects?
While specific side effects are not listed here, similar medications such as Treprostinil (Remodulin®) can cause site pain with subcutaneous delivery and may include headaches, diarrhea, nausea; these could also be expected with UT-15C but potentially lessened due to its oral form.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe blood flow problems in my legs.
Select...
I cannot become pregnant or am using birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
To obtain peak and trough treprostinil plasma levels in CLI subjects
ž Ambulatory status
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Who is running the clinical trial?
Southern Illinois UniversityOTHER
36 Previous Clinical Trials
15,261 Total Patients Enrolled
Southern Arizona Vascular InstituteLead Sponsor
Colleen Johnson, MDPrincipal InvestigatorSouthern Illinois University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a surgery or procedure on my blood vessels.I have not taken any prostaglandin medications in the last 30 days.I do not have unstable blood pressure or sudden kidney, heart, or lung failure.I have a wound with severe gangrene or visible tendons.I have severe blood flow problems in my legs.I had surgery or a procedure for my leg artery disease within the last 30 days.My condition is severe leg artery blockage at the most advanced stage.I have an unhealed cut from a toe or part of my foot being removed.I cannot become pregnant or am using birth control.I have been using painkillers for at least two weeks to manage my pain without moving.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to partake in this clinical trial?
"For this research project, 20 ischemic patients between the ages of 45 and 85 are sought. Eligibility criteria for participation include signing an applicable consent form, being permanently infertile or using dependable contraception methods if female and having taken analgesics to manage their rest pain prior to enrollment."
Answered by AI
Is this research endeavor currently seeking participants?
"As listed on clinicaltrials.gov, this investigation is no longer accepting participants; the trial was initially posted on November 1st 2006 and last updated March 7th 2007. Despite its cessation of recruitment, there are 404 other ongoing trials that require volunteers."
Answered by AI
Is the current research recruiting elderly participants?
"According to the criteria listed in this medical trial, those eligible must be aged between 45 and 85 years old."
Answered by AI
What potential risks does this intervention pose for individuals?
"Having reviewed the available information, we at Power rate the safety of this intervention as a 2 since it is currently in Phase 2 trials. That suggests that some data exists to support its security but none for efficacy."
Answered by AI
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