Peripheral Arterial DiseaseNCT04755335
Ultrasonic Perfusion Estimation in Calf Muscle
An observational study of Peripheral Arterial Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Ultrasound
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 29 May 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject population will include n=300 symptomatic patients with claudication, at risk for PAD (150 abnormal ABI and 100 with normal ABI), male and female, age ≥18 years and are referred Mayo Clinic Vascular Center due to claudication or atypical leg symptoms for ABI examination. In addition to comparing to the group of Normal (symptomatic patients with normal resting and exercise ABI), the study will also include 50 healthy volunteers with normal ABI and with no history of smoking cardiovascular and metabolic disorders, including diabetes mellitus.
Who may be able to join
- Male and female volunteers > 18 years old.
- Male and female volunteers with symptom of claudication and suspected peripheral arterial disease (PAD) who are scheduled for vascular testing.
Who cannot join
- Patients with gangrene.
- Patients with lower leg amputation.
- Having ulcer and any health condition that does not allow proper use of ultrasound scanning.
- People considered in "vulnerable" populations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Ultrasonic Perfusion Imaging of Peripheral Vascular Disease
The purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.
Read the detailed description
The clinical manifestations of peripheral arterial disease (PAD), regardless of etiology, are due to a lack of blood flow to the musculature relative to its metabolism, which results in pain in the affected muscle groups. PAD affecting the lower extremities causes claudication, cramping pain in the calf muscle, thigh or hip muscle induced by exercise. The initial test for evaluation of patients with claudication is ankle brachial index (ABI).
Therefore, a non-invasive and affordable US technique that can quantify blood perfusion and microvasculature density, without using contrast agent, will improve PAD detection in early stage and can monitor the disease progress as well as the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative imaging of perfusion that would help separating PAD from non-PAD and monitor the disease progression and treatment response.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Ultrasound
- Keywords
- Blood flow, Blood Vessel, Ischemia, Calf muscle pain, Vascular, Ultrasound, Intermitant claudication, Cramp
- Medical subject headings
- Peripheral Arterial Disease, Ischemia, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
In this project, The investigators will use Alpinion ECUBE-12R (Alpinion, Bothell, WA) US platform. This state-of-the-art research US machine provides beam formed as well as Plane-Wave imaging options that allow high frame rate imaging. The investigators have characterized the acoustic output of this system for safe human studies and obtained the IRB approval for human studies. It should be noted that our technique is not limited to the Alpinion system; the investigators can also use other US systems, such as Verasonics, Vantage, (Redmond, WA). This technique can be adapted to other modern US machines in the future.
| Study group | Role | What they receive |
|---|---|---|
| Early detection of PAD, assessment of the disease progression and treatment response | 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. Receives: Diagnostic Test: Ultrasound | |
| Healthy volunteers | A group of healthy volunteers ages 18 and above with no history of smoking, cardiovascular, diabetes or surgery on legs. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.
Measured: 4 yeas
Secondary outcomes (1)
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.
At each time point after the treatment, the perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start28 Feb 2020
- Primary completion15 Feb 2023
- Study completion29 May 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
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, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755335
- Sponsor's protocol ID
- 19-002559
- Other IDs
- R01HL148664, 5R01HL148664-02
- Status last verified
- Apr 2025
- First submitted
- 2 Feb 2021
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Perfusion Imaging of Peripheral Vascular Disease
- ClinicalTrials.gov ID
- NCT04755335
- Acronym / sponsor ID
- 19-002559
- Conditions
- Peripheral Arterial Disease
- Keywords
- Blood flow, Blood Vessel, Ischemia, Calf muscle pain, Vascular, Ultrasound, Intermitant claudication, Cramp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 16 Feb 2021 (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 evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.
Detailed description
The clinical manifestations of peripheral arterial disease (PAD), regardless of etiology, are due to a lack of blood flow to the musculature relative to its metabolism, which results in pain in the affected muscle groups. PAD affecting the lower extremities causes claudication, cramping pain in the calf muscle, thigh or hip muscle induced by exercise. The initial test for evaluation of patients with claudication is ankle brachial index (ABI).
Therefore, a non-invasive and affordable US technique that can quantify blood perfusion and microvasculature density, without using contrast agent, will improve PAD detection in early stage and can monitor the disease progress as well as the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative imaging of perfusion that would help separating PAD from non-PAD and monitor the disease progression and treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early detection of PAD, assessment of the disease progression and treatment response | – | Diagnostic Test: UltrasoundThe 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. |
| Healthy volunteers | – | Diagnostic Test: UltrasoundA group of healthy volunteers ages 18 and above with no history of smoking, cardiovascular, diabetes or surgery on legs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject population will include n=300 symptomatic patients with claudication, at risk for PAD (150 abnormal ABI and 100 with normal ABI), male and female, age ≥18 years and are referred Mayo Clinic Vascular Center due to claudication or atypical leg symptoms for ABI examination. In addition to comparing to the group of Normal (symptomatic patients with normal resting and exercise ABI), the study will also include 50 healthy volunteers with normal ABI and with no history of smoking cardiovascular and metabolic disorders, including diabetes mellitus.
Key inclusion criteria (2 listed)
- Male and female volunteers > 18 years old.
- Male and female volunteers with symptom of claudication and suspected peripheral arterial disease (PAD) who are scheduled for vascular testing.
Key exclusion criteria (4 listed)
- Patients with gangrene.
- Patients with lower leg amputation.
- Having ulcer and 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 |
|---|---|---|
| UltrasoundIn this project, The investigators will use Alpinion ECUBE-12R (Alpinion, Bothell, WA) US platform. This state-of-the-art research US machine provides beam formed as well as Plane-Wave imaging options that allow high frame rate imaging. The investigators have characterized the acoustic output of this system for safe human studies and obtained the IRB approval for human studies. It should be noted that our technique is not limited to the Alpinion system; the investigators can also use other US systems, such as Verasonics, Vantage, (Redmond, WA). This technique can be adapted to other modern US machines in the future. | Diagnostic test | Early detection of PAD, assessment of the disease progression and treatment response, Healthy volunteers |
Primary outcome
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
Time frame: 4 yeas
Perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.
1 secondary outcome
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.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- 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. This study is not recruiting at the moment.
Azra Alizad, MD 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?
An observational study of 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 23 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 yeas). 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 23 Apr 2025.