Comparison of Systolic Rise Time to Duplex as the Gold Standard 1.0
Research type
Research Study
Full title
Comparison between systolic rise time (SRT) at the ankle and Doppler ultrasound as the gold standard: Can SRT be an alternative quantifiable measure of peripheral arterial disease in the diabetic population?
IRAS ID
185477
Contact name
Hannah Williamson
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Background: People with diabetes are two times more likely to develop cardiovascular disease, such as peripheral arterial disease (PAD). PAD limits the amount of blood available to supply the peripheral tissues of the body. PAD is currently diagnosed by calculating a ratio of ankle to arm blood pressure. This is called the ankle-brachial pressure index (ABPI). For people with diabetes this method is limited. With increasing age the arteries become hard and stiff. With diabetes this becomes more marked. Consequently, the blood pressure cuff used for ABPI measurements cannot compress the arteries and take a reading. New diagnostic tools are being investigated to help find a solution.
Aims: The first aim of the proposed study is to determine the accuracy of a new diagnostic tool, the systolic rise time (SRT), compared to a full leg Doppler ultrasound scan as the gold standard of reference. The second aim is to determine its accuracy when used for diabetic and non-diabetic participants.
Methodology: People with and without diabetes will be invited to take part. They will be asked to lay for 15 minutes before tests begin. The SRT of blood flow will be measured in the arteries at ankle level, using Doppler ultrasound. Then, a resting ABPI will be performed. After, the stomach and each leg, from groin to ankle, will be scanned using Doppler ultrasound and a healthcare scientist will record the degree of PAD in the leg. Proposed Analysis: The recorded data will be analysed using the appropriate statistics to determine whether SRT measurements and the Doppler ultrasound have a correlation. If they do, further statistics will be applied to assess the relationship strength. Through this analysis the proposed study hopes to aid efforts in finding an alternative diagnostic tool for PAD that will benefit people with diabetes who cannot have ABPI measurements.REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0436
Date of REC Opinion
1 Dec 2015
REC opinion
Further Information Favourable Opinion