Clinical Research Directory
Browse clinical research sites, groups, and studies.
Automated ABPI in Peripheral Arterial Disease a Pilot Study
Sponsor: Hull University Teaching Hospitals NHS Trust
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2026-06-24
Completion Date
2028-09
Last Updated
2026-10-01
Healthy Volunteers
Yes
Conditions
Interventions
MESI mTablet
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.
BlueDop vascular Expert (BlueDopVE)
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.
Locations (1)
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom