GP Ability Study v1
Research type
Research Study
Full title
Can the introduction of rapid and automatic Ankle Brachial Pressure and Pulse Volume measuring device into General Practice identify the presence or absence of Peripheral Arterial Disease in cardiovascular risk groups?
IRAS ID
172242
Contact name
Jane Lewis
Contact email
Sponsor organisation
Cardiff and Vale UHB
Clinicaltrials.gov Identifier
18116, UKCRN
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
Major blood vessels facilitating flow to the lower limb and foot are paramount in maintaining the ability for the skin to heal and overall foot health. The Ankle Brachial Pressure Index (ABPI) has been a useful tool for identifying disease of these major lower limb peripheral arteries and can be carried out in primary care. However traditional ABPI testing is floored due to it being time consuming and requires a skilled clinician to perform the assessment. With the occurrence of calcification within the arterial wall the ABPI can be unreliable particularly for those with diabetes or chronic kidney disease. As a consequence it has not been readily employed in GP practices resulting in unnecessary costly secondary care. It has also been estimated that 60% of those with PAD are asymptomatic and could therefore go undiagnosed until serious clinical symptoms develop such as ulceration and amputation incurring not only a large human burden but also a financial burden on the health service.
The Pulse Volume Recordings (PVR) identifies all blood flow into the lower limb and foot thus including not only the main arteries but smaller blood vessels and collaterals and is not affected by the presence of medial calcification. Consequently the use of a reliable automatic machine that measures PVR in addition to ankle pressures and does not require a rest period or clinical skill to assess an individual’s peripheral arterial flow in primary care could reduce unnecessary referrals considered to be symptomatic and identify asymptomatic peripheral arterial disease, allowing for earlier lifestyle interventions and more informed referrals to secondary care.
The objective of this study is to establish whether the introduction of rapid and automatic ABPI/PVR measuring device into General Practice can identify the presence/absence of PAD in those with hypertension and/or diabetes mellitus.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0129
Date of REC Opinion
18 Mar 2015
REC opinion
Further Information Favourable Opinion