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Ultrasound Perfusion Measurement for Peripheral Artery Disease
N/A
Waitlist Available
Led By Azra Alizad, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test whether ultrasound can show if a treatment for peripheral artery disease is working by measuring changes in the microvessels and perfusion.
Who is the study for?
This trial is for men and women over 18 who have symptoms of claudication, which often indicates peripheral arterial disease (PAD), and are scheduled for vascular testing. It's not suitable for patients with gangrene, lower leg amputations, ulcers, or conditions that prevent ultrasound use. Vulnerable populations are also excluded.Check my eligibility
What is being tested?
The study is exploring the effectiveness of an ultrasound technique to track how PAD progresses and responds to treatment by looking at changes in tiny blood vessels and blood flow.See study design
What are the potential side effects?
Since this trial involves non-invasive ultrasound imaging, there are minimal side effects expected. However, some individuals might experience discomfort during the procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aim 1: Determine the efficacy of ultrasonic perfusion imaging for early detection of PAD. The goal is to quantify the perfusion of cuff muscle in patients with lower leg claudication and compare the results to those obtained in healthy individuals
Secondary outcome measures
Aim 2: Determine the efficacy of ultrasonic perfusion imaging for assessment of treatment response in PAD patients. The goal is to quantify the perfusion of the cuff muscle in PAD patients in 3 time points, 6 months, and every year after treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Early detection of PAD, assessment of the disease progression and treatment responseExperimental Treatment1 Intervention
The objective of this arm of the study is to evaluate the potentials of Ultrasound Perfusion imaging technique for early detection of peripheral arterial disease in patients and assess the disease progression and monitor the treatment response.
The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative perfusion estimation of calf muscle that would separate PAD from non-PAD and help early detection of PAD and would help monitoring the disease progression and treatment response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~1950
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,903 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
100 Patients Enrolled for Peripheral Arterial Disease
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,455 Total Patients Enrolled
52 Trials studying Peripheral Arterial Disease
108,756 Patients Enrolled for Peripheral Arterial Disease
Azra Alizad, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
2,240 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are considered at higher risk.I have had an amputation below the knee.I am over 18 years old.I have an ulcer or a condition that prevents ultrasound use.I have gangrene.I have leg pain when walking and might have peripheral arterial disease.
Research Study Groups:
This trial has the following groups:- Group 1: Early detection of PAD, assessment of the disease progression and treatment response
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.
Are new volunteers currently being sought after for this experiment?
"The details provided on clinicaltrials.gov demonstrate that this particular trial is not actively recruiting patients anymore - the study was posted on February 28th 2020 and last updated February 10th 2022. However, there are an abundance of other trials currently accepting participants for enrollment; 217 in total."
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