Skip to main content
OpenTrials
Completed

NCT Number: NCT04058626

TEsting for Arterial Disease in Diabetes (TrEAD) Study

This study will focus on determining;

* How accurate the test is in detecting poor circulation * How it's accuracy compares to other commonly used tests, and * Whether test results are linked to the chance of ulcer healing or amputation. Across 2 hospitals, 305 diabetic patients will be scanned using the focused ultrasound test as well as other commonly used tests to detect poor circulation. Their results will be compared to a full version of the ultrasound test to identify the most accurate.

Completed

Looking for future studies?

Notify Me

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 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

Imperial College NHS Healthcare Trust, London, United Kingdom

Loading trial locations.

About this study

In the UK, over 7,000 amputations are performed each year because of diabetes. Most of these (80%) occur when a foot wound, also known as an ulcer, does not heal. The most important cause of this is poor circulation to the feet. Currently, there are no accurate tests that foot specialists can use to detect poor circulation when they see patients. Because of this, poor circulation can be missed and its treatment delayed.

A focused ultrasound test at the ankle, using a sensor and gel on the skin, can detect poor circulation. It is safe, painless and I have previously proven that it can be learned and performed quickly. It may help avoid amputations by detecting poor circulation so that it can be treated quickly.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All diabetic patients presenting to the diabetic foot clinics will be eligible for the study.

Exclusion criteria

  • Patients unable to provide informed consent will also be excluded.

Treatment and study plan

Transcutaneous pressure of oxygen (TcPO2)

Diagnostic Test

Measurements will be taken from the dorsum of the foot using an automated machine equipped with Clark electrodes.

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.

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.

Duplex Assist

Diagnostic Test

Continuous Doppler device which gives visual display of arterial spectral waveform at the ankle.

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 DPA and PTA.

Primary outcomes

  1. Diagnostic Accuracy

    Time frame: 1 hour; all tests will be performed on the same day of presentation.

    Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a full lower limb Duplex Ultrasound scan (reference test).

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Official study title

Comparative Diagnostic Accuracy Study of Bedside Tests Used to Detect Arterial Disease in Diabetes:

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2019
Registry last updated
Sep 2, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.