In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult. A number of tests exist to detect poor circulation (known as peripheral arterial disease (PAD)). However, there is confusion as to which is the gold standard. The DM PAD study aims to determine the diagnostic performance of index tests (audible handheld Doppler, visual handheld Doppler, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in patients with diabetes as determined by a reference test (CTA or MRA).
Study Type
OBSERVATIONAL
Enrollment
604
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle. To be used in 3 participating centers only.
Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom
Cardiff and Vale UHB
Cardiff, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Central London Community Healthcare NHS Trust sites
London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
...and 7 more locations
Diagnostic Accuracy
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).
Time frame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Diagnostic Accuracy - Ratios
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).
Time frame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Health Economic Outcome - Cost Effectiveness
Incremental cost-effectiveness ratio at 5 years.
Time frame: 5 years
Health Economic Outcome - Cost Effectiveness (QALY)
Incremental cost-effectiveness ratio at 5 years.
Time frame: 5 years
Patient Acceptability
Patients will be asked to rate their experience of each index test on a Likert scale.
Time frame: 1 hour: all index tests will be performed on the same day of presentation.
Technical Success
Inability to perform, refusal and discontinuation of tests will be documented
Time frame: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
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