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

CompletedOBSERVATIONAL
Enrollment

604

Participants

Timeline

Start Date

March 14, 2022

Primary Completion Date

February 28, 2024

Study Completion Date

February 28, 2024

Conditions
Diabetic FootPeripheral Arterial DiseaseDiabetic Foot UlcerPeripheral Vascular DiseasesPeripheral Artery DiseaseCritical Limb IschemiaCritical 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."

Trial Locations (17)

SS16 5NL

Mid and South Essex NHS Foundation Trust, Basildon

CF14 4XW

Cardiff and Vale UHB, Cardiff

DE22 3NE

University Hospitals of Derby and Burton NHS Foundation Trust, Derby

G12 0XH

NHS Greater Glasgow and Clyde, Glasgow

HU3 2JZ

Hull University Teaching Hospitals NHS Trust, Hull

LE1 5WW

University Hospitals of Leicester NHS Trust, Leicester

NW1 5JD

Central London Community Healthcare NHS Trust sites, London

SW10 9NH

Chelsea and Westminster Hospital NHS Foundation Trust, London

SW17 0QT

St George's University Hospitals NHS Foundation Trust, London

W6 8RF

Imperial College Healthcare NHS Trust, London

Unknown

Hammersmith and Fulham Partnership, London

TS4 3BW

South Tees Hospitals NHS Foundation Trust, Middlesbrough

NG5 1PB

Nottingham University Hospitals (NUH) NHS Trust, Nottingham

OX4 2PG

Oxford University Hospitals NHS Foundation Trust, Oxford

PL6 8DH

University Hospitals Plymouth NHS Trust, Plymouth

SO16 6YD

University Hospitals Southampton NHS Foundation Trust, Southampton

WR5 1DD

Worcestershire Acute Hospitals NHS Trust, Worcester

All Listed Sponsors
collaborator

University of Leicester

OTHER

collaborator

University of Edinburgh

OTHER

collaborator

Universidad de Granada

OTHER

lead

Imperial College London

OTHER