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Assessing the Diagnostic Accuracy of AUTOmated Ankle-Brachial Pressure Index Devices Across the Spectrum of Peripheral Arterial Disease (AUTO-PAD)- A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
United Kingdom
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
Contact Information
Primary
Jon Prosser
jonathon.prosser@nhs.net
01482 674703
Backup
Judith Long
judith.long3@nhs.net
Time Frame
Start Date: 2026-06-24
Estimated Completion Date: 2028-09
Participants
Target number of participants: 400
Treatments
Group 1 Asymptomatic
Participants with one or more CVD risk factors
Group 2a Suspected PAD (intermittent claudication)
Partcipants presenting with Suspected PAD (intermittent claudication)
Group 2b Suspected PAD (CLTI)
Participants presenting with tissue loss or rest pain
Group 3 Post-bypass surveillance
Participants presenting for post-bypass surveillance
Sponsors
Leads: Hull University Teaching Hospitals NHS Trust

This content was sourced from clinicaltrials.gov