Peripheral Arterial DiseaseNCT06952543
Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease
A study testing Ultrasound Imaging in people with Peripheral Arterial Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Ultrasound Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2025to 30 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient volunteers:
- Male and Female, ages 18 years old and up
- Symptom of claudication and suspected for PAD
- Scheduled for vascular testing.
- Healthy volunteers:
- Male and female, ages 18-75 years old and up
- Normal BMI
- No history of smoking, cardiovascular disease, or diabetes.
Who cannot join
- Patient volunteers:
- Patients with gangrene
- Patients having surgery or stent
- Patients with ulcer on their leg
- Any health condition that does not allow proper use of ultrasound scanning
- People considered in "vulnerable" populations.
Show all 11Show fewer
- Healthy volunteers:
- Include volunteers with BMI not more than 30
- No history of smoking
- No history of (diabetes, hypertension, cardiovascular diseases)
- People considered in "vulnerable" populations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Azra Alizad, MD, 507-538-1727, alizad.azra@mayo.edu
Fatima Zohra, MS, 5075382234, Zohra.Fatima@mayo.edu
About this study
Official title: Ultrasound Perfusion Estimation for Assessment of PAD
The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Ultrasound Imaging
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ImagingDiagnostic test
Non-invasive ultrasound will be performed using Angio Flow Reactivity Analysis (AFRA)
The ultrasound probe will be attached to the subject's calf muscle and a pressure cuff will be secured around thigh. Ultrasound data will be collected for 1 minute.
The cuff will then be induced to a tolerable pressure of no more than 160 mm Hg, and ultrasound data will be collected for 3 minutes while cuff is inflated.
The cuff pressure will be released, and ultrasound data will be collected for 2 minutes after the release.
Subject will be asked to perform 1 minute plantar flexion exercise, and ultrasound data will be collected for two minutes after the completion of exercise
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD) Receives: Diagnostic Test: Ultrasound Imaging |
| Healthy Volunteers | Experimental | Healthy volunteers with normal ankle-brachial index (ABI) Receives: Diagnostic Test: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of peripheral arterial disease using ultrasound perfusion estimation
Evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ultrasound perfusion estimation compared to a reference standard (e.g., ankle-brachial index [ABI], CT angiography, or MR angiography) in diagnosing PAD.
Measured: Up to 4 years
Secondary outcomes (1)
Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation
To assess longitudinal changes in perfusion values measured via ultrasound following medical, endovascular, or surgical interventions for PAD.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start14 Mar 2025
- Primary completion30 May 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Azra Alizad, Mayo Clinic
- Investigators
- Azra Alizad, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952543
- Sponsor's protocol ID
- 24-002802
- Other IDs
- 1R01HL174785-01
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Perfusion Estimation for Assessment of PAD
- ClinicalTrials.gov ID
- NCT06952543
- Acronym / sponsor ID
- 24-002802
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 1 May 2025 (actual)
- 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.
The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: Ultrasound ImagingSymptomatic patients with claudication, at risk for peripheral arterial disease (PAD) |
| Healthy Volunteers | Experimental | Diagnostic Test: Ultrasound ImagingHealthy volunteers with normal ankle-brachial index (ABI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and Female, ages 18 years old and up
- Symptom of claudication and suspected for PAD
- Scheduled for vascular testing.
- Male and female, ages 18-75 years old and up
- Normal BMI
Key exclusion criteria (11 listed)
- Patients with gangrene
- Patients having surgery or stent
- Patients with ulcer on their leg
- Any health condition that does not allow proper use of ultrasound scanning
- People considered in "vulnerable" populations.
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 |
|---|---|---|
| Ultrasound ImagingNon-invasive ultrasound will be performed using Angio Flow Reactivity Analysis (AFRA) The ultrasound probe will be attached to the subject's calf muscle and a pressure cuff will be secured around thigh. Ultrasound data will be collected for 1 minute. The cuff will then be induced to a tolerable pressure of no more than 160 mm Hg, and ultrasound data will be collected for 3 minutes while cuff is inflated. The cuff pressure will be released, and ultrasound data will be collected for 2 minutes after the release. Subject will be asked to perform 1 minute plantar flexion exercise, and ultrasound data will be collected for two minutes after the completion of exercise | Diagnostic test | Healthy Volunteers, Study Group |
Primary outcome
Detection of peripheral arterial disease using ultrasound perfusion estimation
Time frame: Up to 4 years
Evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ultrasound perfusion estimation compared to a reference standard (e.g., ankle-brachial index [ABI], CT angiography, or MR angiography) in diagnosing PAD.
1 secondary outcome
Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Azra Alizad principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Imaging in people with Peripheral Arterial Disease, run by Mayo Clinic at 1 site 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Detection of peripheral arterial disease using ultrasound perfusion estimation (time frame: Up to 4 years). 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 5 May 2026.