Sponsor: Imperial College London (ref: 21CX7046); IRAS: 301408

Objective

To determine the diagnostic performance of index tests (audible handheld Doppler, visual handheld Doppler, ABPI, exercise ABPI and TBPI) for the diagnosis of peripheral arterial disease (PAD) (poor circulation) in patients with diabetes as determined by a reference test (CTA or MRA).

Design

Multi-centre, open trial. The trial will follow patients up for 2 weeks and will be conducted in approximately 18 participating Trusts in the United Kingdom.

Sample size

A total of 730 patients will be recruited.

Eligibility criteria

Inclusion Criteria

• Aged ≥18 years
• Known history of diabetes

Exclusion Criteria

• PAD status known on imaging
• Known history of PAD intervention
• CTA and MRA contraindications- renal impairment, pregnancy, contrast medium hypersensitivity/allergy, non-compatible implants (MRA only).
• Unable to provide appropriate informed consent.

Primary endpoint

The primary outcome is the sensitivity of the index tests.

Secondary endpoints

• Specificity, likelihood ratios, predictive values and diagnostic odds ratio.
• Health economic outcomes: 1) Cost of the test, including direct costs and amortisation of capital equipment and use of other healthcare resources for prevention and treatment of the disease over a time horizon of 5 years 2) Quality Adjusted Life Years at 5 years. 3) Incremental cost-effectiveness ratio at 5 years
• Patient acceptability
• Technical success
• Inter- and intra-rater reliability: The first 100 volunteering patients will be consented to have index tests repeated by the same operator and by an alternative operator on the same leg.

Randomisation (performed through RedCap)

Consenting eligible patients will be randomised through RedCap.
If you have any problems logging on to RedCap please contact the team via redcap.ectu@ed.ac.uk

Study documents

Coming soon