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

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).

Conditions

• Diabetic Foot
• Peripheral Arterial Disease
• Diabetic Foot Ulcer
• Peripheral Vascular Diseases
• Peripheral Artery Disease
• Critical Limb Ischemia
• Critical Lower Limb Ischemia

Interventions

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.

Sponsors & Collaborators

• University of Leicester

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• Universidad de Granada

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Usman Jaffer · Chief Investigator

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-14

Primary Completion

2024-02-28

Completion

2024-02-28

Countries

• United Kingdom

Study Locations