Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes (DM PAD)

August 13, 2025 updated by: Imperial College London

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

604

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Basildon, United Kingdom, SS16 5NL
        • Mid and South Essex NHS Foundation Trust
      • Cardiff, United Kingdom, CF14 4XW
        • Cardiff and Vale UHB
      • Derby, United Kingdom, DE22 3NE
        • University Hospitals of Derby and Burton NHS Foundation Trust
      • Glasgow, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde
      • Hull, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust
      • London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital NHS Foundation Trust
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust
      • London, United Kingdom, NW1 5JD
        • Central London Community Healthcare NHS Trust sites
      • London, United Kingdom
        • Hammersmith and Fulham Partnership
      • Middlesbrough, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals (NUH) NHS Trust
      • Oxford, United Kingdom, OX4 2PG
        • Oxford University Hospitals NHS Foundation Trust
      • Plymouth, United Kingdom, PL6 8DH
        • University Hospitals Plymouth NHS Trust
      • Southampton, United Kingdom, SO16 6YD
        • University Hospitals Southampton NHS Foundation Trust
      • Worcester, United Kingdom, WR5 1DD
        • Worcestershire Acute Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with a diagnosis of diabetes.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participating Centre
To complete all index tests and reference scan
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: Audible handheld Doppler
Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
Diagnostic test: Visual handheld Doppler
Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy
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 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
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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Economic Outcome - Cost Effectiveness
Time Frame: 5 years
Incremental cost-effectiveness ratio at 5 years.
5 years
Health Economic Outcome - Cost Effectiveness (QALY)
Time Frame: 5 years
Incremental cost-effectiveness ratio at 5 years.
5 years
Patient Acceptability
Time Frame: 1 hour: all index tests will be performed on the same day of presentation.
Patients will be asked to rate their experience of each index test on a Likert scale.
1 hour: all index tests will be performed on the same day of presentation.
Technical Success
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.
Inability to perform, refusal and discontinuation of tests will be documented
6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University of Edinburgh
Universidad de Granada
University of Leicester

Investigators

  • Principal Investigator: Usman Jaffer, Chief Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21CX7046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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