Peripheral Arterial Disease (PAD)AUTO-PADNCT07850349
Automated ABPI in Peripheral Arterial Disease a Pilot Study
An observational study of Peripheral Arterial Disease (PAD) and Ankle Brachial Index, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD [IC; including mild moderate and severe IC based on the Rutherford classification (21) and CLTI] and post-bypass surveillance). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease (PAD), Ankle Brachial Index, Diagnostic Accuracy
- What is being tested?
- MESI mTablet and BlueDop vascular Expert (BlueDopVE)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2026to Sep 2028
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Asymptomatic PAD: Patients identified by the GP (PIC sites). Records screened to identify 'at risk' of PAD with >1 cardiovascular disease risk factor Group 2: Suspected symptomatic PAD: 2a. Patients with suspected IC referred to dedicated nurse-led claudication clinic. Group 2b. Patients with suspected CLTI referred to dedicated urgent vascular (HOT) clinic. Group 3: Patients undergoing surveillance seen in dedicated clinics by vascular scientists
Who may be able to join
- Group 1: Asymptomatic
- Adults aged 18 and over
- At risk of PAD with ≥1 cardiovascular risk factor
- No previous diagnosis of PAD
- English speaking and able to understand test protocols
- Group 2a: Suspected PAD (intermittent claudication)
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- Adults aged 18 and over
- Referred and booked into the nurse-led claudication clinic due to signs/symptoms in keeping with suspected intermittent claudication
- English speaking and able to understand test protocols
- Group 2b: Suspected PAD (CLTI)
- Adults aged 18 and over
- Referred and booked into the vascular HOT clinic due to signs/symptoms in keeping with suspected CLTI
- English speaking and able to understand test protocols
- Group 3: Post-bypass surveillance
- Adults aged 18 and over
- History of lower limb bypass surgery, enrolled in and attending the local surveillance programme
- English speaking and able to understand test protocols
Who cannot join
- Patients who are unable to provide informed consent
- Recent (≤4 weeks) lower-limb surgery
- Ulcers, casts or bandages that cannot or should not be compressed
- Patients who have had a therapeutic intervention (stent or graft) which extends to the ankle
- Patients with known or suspected acute deep vein thrombosis (DVT) or superficial thrombophlebitis
- Marked oedema in one or both feet
Show all 10Show fewer
- Inability to tolerate a supine position
- Patients with spasms or tremors of any kind
- Arm arteriovenous fistula
- Inability to cooperate due to impaired cognition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Judith Long contact
United Kingdom1 site, 1 recruiting
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
James Illingworth, 01482 461903, james.illingworth3@nhs.net
About this study
Official title: Assessing the Diagnostic Accuracy of AUTOmated Ankle-Brachial Pressure Index Devices Across the Spectrum of Peripheral Arterial Disease (AUTO-PAD)- A Pilot Study
The aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD [IC; including mild moderate and severe IC based on the Rutherford classification (21) and CLTI] and post-bypass surveillance). A second aim is to assess their useability and tolerability through semi-structured interviews with patients and clinicians. This means the research will be split into two workstreams.
- Conditions
- Peripheral Arterial Disease (PAD), Ankle Brachial Index, Diagnostic Accuracy, Feasibility Studies
- Being tested
- MESI mTablet, BlueDop vascular Expert (BlueDopVE)
- 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.
MESI mTabletDevice
The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.
BlueDop vascular Expert (BlueDopVE)Device
The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Asymptomatic | Participants with one or more CVD risk factors Receives: Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE) | |
| Group 2a Suspected PAD (intermittent claudication) | Partcipants presenting with Suspected PAD (intermittent claudication) Receives: Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE) | |
| Group 2b Suspected PAD (CLTI) | Participants presenting with tissue loss or rest pain Receives: Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE) | |
| Group 3 Post-bypass surveillance | Participants presenting for post-bypass surveillance Receives: Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Diagnostic accuracy assessed via sensitivity, specificity, positive predictor value (PPV) and negative predictor value (NPV).
Measured: From enrolment to the end of treatment (1 day)
Secondary outcomes (5)
Validity assessed via correlation
Diagnostic performance assessed via area under the receiver operating characteristic (AUROC) curve and the assessment time difference, assessed via measurement of the time taken to perform each automated ABPI assessment and the manual ABPI assessment.
Measured: Data collected at enrolment (1 day)
Diagnostic performance
Assessed via area under the receiver operating characteristic (AUROC) curve.
Measured: Data collected at enrolment (1 day)
Time taken to perform each automated ABPI assessment and the manual ABPI assessment.
Time taken to perform each assessment in seconds
Measured: Data collected at enrolment (1 day)
Qualitative Workstream - Assessment of usability and tolerability of automated devices.
Semi structured interviews analysed using thematic analysis
Measured: Within the 2 year recruitment period
Visual Analogue Scale (VAS) score of 0-10
VAS used to assess tolerability
Measured: Data collected at point of enrolment (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start24 Jun 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease (PAD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850349
- Sponsor's protocol ID
- R4364
- Acronym
- AUTO-PAD
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Diagnostic Accuracy of AUTOmated Ankle-Brachial Pressure Index Devices Across the Spectrum of Peripheral Arterial Disease (AUTO-PAD)- A Pilot Study
- ClinicalTrials.gov ID
- NCT07850349
- Acronym / sponsor ID
- AUTO-PAD / R4364
- Conditions
- Peripheral Arterial Disease (PAD), Ankle Brachial Index, Diagnostic Accuracy, Feasibility Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2026 (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 aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD [IC; including mild moderate and severe IC based on the Rutherford classification (21) and CLTI] and post-bypass surveillance). A second aim is to assess their useability and tolerability through semi-structured interviews with patients and clinicians. This means the research will be split into two workstreams.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Asymptomatic | – | Device: MESI mTablet, Device: BlueDop vascular Expert (BlueDopVE)Participants with one or more CVD risk factors |
| Group 2a Suspected PAD (intermittent claudication) | – | Device: MESI mTablet, Device: BlueDop vascular Expert (BlueDopVE)Partcipants presenting with Suspected PAD (intermittent claudication) |
| Group 2b Suspected PAD (CLTI) | – | Device: MESI mTablet, Device: BlueDop vascular Expert (BlueDopVE)Participants presenting with tissue loss or rest pain |
| Group 3 Post-bypass surveillance | – | Device: MESI mTablet, Device: BlueDop vascular Expert (BlueDopVE)Participants presenting for post-bypass surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Asymptomatic PAD: Patients identified by the GP (PIC sites). Records screened to identify 'at risk' of PAD with >1 cardiovascular disease risk factor Group 2: Suspected symptomatic PAD: 2a. Patients with suspected IC referred to dedicated nurse-led claudication clinic. Group 2b. Patients with suspected CLTI referred to dedicated urgent vascular (HOT) clinic. Group 3: Patients undergoing surveillance seen in dedicated clinics by vascular scientists
Key inclusion criteria (17 listed)
- Group 1: Asymptomatic
- Adults aged 18 and over
- At risk of PAD with ≥1 cardiovascular risk factor
- No previous diagnosis of PAD
- English speaking and able to understand test protocols
Key exclusion criteria (10 listed)
- Patients who are unable to provide informed consent
- Recent (≤4 weeks) lower-limb surgery
- Ulcers, casts or bandages that cannot or should not be compressed
- Patients who have had a therapeutic intervention (stent or graft) which extends to the ankle
- Patients with known or suspected acute deep vein thrombosis (DVT) or superficial thrombophlebitis
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 |
|---|---|---|
| MESI mTabletThe MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD. | Device | Group 1 Asymptomatic, Group 2a Suspected PAD (intermittent claudication), Group 2b Suspected PAD (CLTI), Group 3 Post-bypass surveillance |
| BlueDop vascular Expert (BlueDopVE)The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD. | Device | Group 1 Asymptomatic, Group 2a Suspected PAD (intermittent claudication), Group 2b Suspected PAD (CLTI), Group 3 Post-bypass surveillance |
Primary outcome
Diagnostic Accuracy
Time frame: From enrolment to the end of treatment (1 day)
Diagnostic accuracy assessed via sensitivity, specificity, positive predictor value (PPV) and negative predictor value (NPV).
5 secondary outcomes
Validity assessed via correlation
Time frame: Data collected at enrolment (1 day)
Diagnostic performance
Time frame: Data collected at enrolment (1 day)
Time taken to perform each automated ABPI assessment and the manual ABPI assessment.
Time frame: Data collected at enrolment (1 day)
Qualitative Workstream - Assessment of usability and tolerability of automated devices.
Time frame: Within the 2 year recruitment period
Visual Analogue Scale (VAS) score of 0-10
Time frame: Data collected at point of enrolment (1 day)
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 1 Oct 2026.
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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.
Judith Long contact
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 (PAD) and Ankle Brachial Index, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 17 inclusion and 10 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 1 Oct 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 Kingdom. 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?
Contact Jon Prosser (01482 674703, jonathon.prosser@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: From enrolment to the end of treatment (1 day)). 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 1 Oct 2026.