TEsting for Arterial Disease in Diabetes (TrEAD) Study

Imperial College Healthcare NHS Trust

Status

Completed

Conditions

Diabetic Foot

Peripheral Artery Disease

Peripheral Vascular Diseases

Critical Limb Ischemia

Critical Lower Limb Ischemia

Peripheral Arterial Disease

Diabetic Foot Ulcer

Treatments

Diagnostic Test: Ankle Brachial Pressure Index (ABPI)

Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan)

Diagnostic Test: Toe Brachial Pressure Index (TBPI)

Diagnostic Test: Duplex Assist

Diagnostic Test: Transcutaneous pressure of oxygen (TcPO2)

Study type

Observational

Funder types

Other

Identifiers

NCT04058626

17HH4091

Details and patient eligibility

About

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.

Full description

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.

Enrollment

305 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria