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Clinical trial Recruiting at 1 site Observational Ages 18 and up

Automated ABPI for Peripheral Artery Disease: A Pilot Look at Two Devices

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

Run by Hull University Teaching Hospitals NHS Trust · NCT07850349 · Data updated 2026-11-12

This pilot checks if two automated ankle-brachial pressure index devices can reliably detect PAD across symptom levels and after bypass surgery, using patient and clinician feedback for practicality.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorHull University Teaching Hospitals NHS Trust
Government
Locations1 site (Hull)
StatusRecruiting
StartedJune 24, 2026
Main results expectedSeptember 2028
Study endsSeptember 2028
Registry record updatedOctober 1, 2026
Trial IDNCT07850349 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 and older at risk for PAD, including asymptomatic individuals, those with suspected PAD (intermittent claudication or CLTI), and post-bypass surveillance patients, who can understand test protocols in English.

Probably not a fit

Patients with inability to consent or non-English speakers may not directly benefit from the usability aspects of the study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot compares two automated ABPI devices, MESI mTablet and BlueDopVE, to determine diagnostic accuracy across asymptomatic PAD, suspected PAD (intermittent claudication and CLTI), and post-bypass surveillance. The study uses two workstreams: device testing for accuracy and semi-structured interviews to assess usability and tolerability. Participants include adults with cardiovascular risk who may or may not have PAD, across multiple clinical settings within Hull. The results will inform feasibility and potential integration into routine PAD assessment. No therapeutic intervention is involved; the focus is on diagnostic performance and user experience.

Why it matters

Potential benefit: If successful, the devices could simplify and speed up PAD screening and monitoring in clinical practice.

How similar studies have gone: Previous work in automated ABPI approaches has shown promise in diagnostic consistency, though specific device comparisons in this dual-workstream pilot are exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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
* History of lower limb bypass surgery, enrolled in and attending the local surveillance programme
* English speaking and able to understand test protocols

Exclusion Criteria:

* 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

Where it's running

  • Hull University Teaching Hospitals NHS Trust
    Hull, United Kingdom     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Peripheral Arterial Disease (PAD) 2Diagnostic Accuracy 2Feasibility Studies 21Hull University Teaching Hospitals NHS Trust 12
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.