Automated ABPI in Peripheral Arterial Disease a Pilot Study

NCT07850349 | Recruiting

• 1 other identifier: R4364
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  Diagnostic accuracy assessed via sensitivity, specificity, positive predictor value (PPV) and negative predictor value (NPV).

  From enrolment to the end of treatment (1 day)

Secondary Outcomes (5)

• Validity assessed via correlation

  Data collected at enrolment (1 day)

• Diagnostic performance

  Data collected at enrolment (1 day)

• Time taken to perform each automated ABPI assessment and the manual ABPI assessment.

  Data collected at enrolment (1 day)

• Qualitative Workstream - Assessment of usability and tolerability of automated devices.

  Within the 2 year recruitment period

• Visual Analogue Scale (VAS) score of 0-10

  Data collected at point of enrolment (1 day)

Study Arms (4)

Group 1 Asymptomatic

Participants with one or more CVD risk factors

Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE)

Group 2a Suspected PAD (intermittent claudication)

Partcipants presenting with Suspected PAD (intermittent claudication)

Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE)

Group 2b Suspected PAD (CLTI)

Participants presenting with tissue loss or rest pain

Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE)

Group 3 Post-bypass surveillance

Participants presenting for post-bypass surveillance

Device: MESI mTablet; Device: BlueDop vascular Expert (BlueDopVE)

Interventions

MESI mTablet DEVICE

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.

Group 1 Asymptomatic; Group 2a Suspected PAD (intermittent claudication); Group 2b Suspected PAD (CLTI); Group 3 Post-bypass surveillance

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.

Group 1 Asymptomatic; Group 2a Suspected PAD (intermittent claudication); Group 2b Suspected PAD (CLTI); Group 3 Post-bypass surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• Inability to tolerate a supine position
• Patients with spasms or tremors of any kind
• Arm arteriovenous fistula
• Inability to cooperate due to impaired cognition

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Jon Prosser

CONTACT

01482 674703; jonathon.prosser@nhs.net

Judith Long

CONTACT

judith.long3@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 30, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

GB (1)