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Recruiting NCT07850349

Automated ABPI in Peripheral Arterial Disease a Pilot Study

Conditions: Peripheral Arterial Disease (PAD), Ankle Brachial Index, Diagnostic Accuracy, Feasibility Studies

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 400
Sponsor: Hull University Teaching Hospitals NHS Trust

Location: Hull University Teaching Hospitals NHS Trust Hull

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.

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07850349). StuddyBuddy aggregates publicly available trial information.