Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
DM PAD
1 other identifier
observational
604
1 country
17
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedResults Posted
Study results publicly available
September 3, 2025
CompletedSeptember 3, 2025
August 1, 2025
2 years
August 4, 2021
June 17, 2025
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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).
6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Secondary Outcomes (4)
Health Economic Outcome - Cost Effectiveness
5 years
Health Economic Outcome - Cost Effectiveness (QALY)
5 years
Patient Acceptability
1 hour: all index tests will be performed on the same day of presentation.
Technical Success
6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Study Arms (1)
Participating Centre
To complete all index tests and reference scan
Interventions
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.
Eligibility Criteria
Adult patients with a diagnosis of diabetes.
You may qualify if:
- Aged ≥18 years
- Known history of diabetes
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- University of Leicestercollaborator
- University of Edinburghcollaborator
- Universidad de Granadacollaborator
Study Sites (17)
Mid and South Essex NHS Foundation Trust
Basildon, SS16 5NL, United Kingdom
Cardiff and Vale UHB
Cardiff, CF14 4XW, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G12 0XH, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW, United Kingdom
Central London Community Healthcare NHS Trust sites
London, NW1 5JD, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
Hammersmith and Fulham Partnership
London, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW, United Kingdom
Nottingham University Hospitals (NUH) NHS Trust
Nottingham, NG5 1PB, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX4 2PG, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH, United Kingdom
University Hospitals Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, WR5 1DD, United Kingdom
Related Publications (1)
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.
PMID: 36328388DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Burgess
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Usman Jaffer
Chief Investigator
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 17, 2021
Study Start
March 14, 2022
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
September 3, 2025
Results First Posted
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share