Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
NCT ID: NCT05009602
Last Updated: 2025-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
604 participants
OBSERVATIONAL
2022-03-14
2024-02-28
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Participating Centre
To complete all index tests and reference scan
Toe Brachial Pressure Index (TBPI)
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
Ankle Brachial Pressure Index (ABPI)
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.
Exercise Ankle Brachial Pressure Index (ABPI)
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 handheld Doppler
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Visual handheld Doppler
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)
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.
Interventions
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Toe Brachial Pressure Index (TBPI)
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
Ankle Brachial Pressure Index (ABPI)
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.
Exercise Ankle Brachial Pressure Index (ABPI)
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 handheld Doppler
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Visual handheld Doppler
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)
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.
Eligibility Criteria
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Inclusion Criteria
* Known history of diabetes
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Leicester
OTHER
University of Edinburgh
OTHER
Universidad de Granada
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Usman Jaffer
Role: PRINCIPAL_INVESTIGATOR
Chief Investigator
Locations
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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
Hammersmith and Fulham Partnership
London, , United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Nottingham University Hospitals (NUH) NHS Trust
Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
University Hospitals Southampton NHS Foundation Trust
Southampton, , United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, , United Kingdom
Countries
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References
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Normahani P, Burgess L, Norrie J, Epstein DM, Kandiyil N, Saratzis A, Smith S, Khunti K, Edmonds M, Ahluwalia R, Coward T, Hartshorne T, Ashwell S, Shalhoub J, Pigott E, Davies AH, Jaffer U; DM PAD study investigators. Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study. BMJ Open. 2022 Nov 3;12(11):e066950. doi: 10.1136/bmjopen-2022-066950.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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21CX7046
Identifier Type: -
Identifier Source: org_study_id
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