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NCT Number: NCT05009602

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

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).

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Key information

Conditions

Diabetic Foot Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Critical Limb Ischemia Critical Lower Limb Ischemia Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Ulcer Diabetic Neuropathies Disease Attributes Endocrine System Diseases Foot Ulcer Ischemia Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toe Brachial Pressure Index (TBPI)

Diagnostic Test

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)

Diagnostic Test

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)

Diagnostic Test

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

Diagnostic Test

Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.

Visual handheld Doppler

Diagnostic Test

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)

Diagnostic Test

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Health Economic Outcome - Cost Effectiveness

    Time frame: 5 years

    Incremental cost-effectiveness ratio at 5 years.

  2. Health Economic Outcome - Cost Effectiveness (QALY)

    Time frame: 5 years

    Incremental cost-effectiveness ratio at 5 years.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Universidad de Granada
  • University of Edinburgh
  • University of Leicester

Registry information

Acronym: DM PAD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2021
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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