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Automated ABPI in Peripheral Arterial Disease a Pilot Study

Recruitingn/aAges 18 Years - anyAllHull University Teaching Hospitals NHS Trust
NCT07850349 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • MESI mTablet
  • BlueDop vascular Expert (BlueDopVE)
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Where

1 site
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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