TEsting for Arterial Disease in Diabetes (TrEAD) Study

Completed

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

• Registration Number: NCT04058626
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-03-04
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Results First Submitted: 2021-01-15
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Results First Posted: 2021-09-02
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	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).

Trial Locations

Locations (2)

Imperial College NHS Healthcare Trust; 🇬🇧 London, United Kingdom

West Middlesex University Hospital; 🇬🇧 London, United Kingdom