TEsting for Arterial Disease in Diabetes (TrEAD) Study

September 1, 2021 updated by: Imperial College Healthcare NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, TW76AF
        • West Middlesex University Hospital
      • London, United Kingdom, W21NY
        • Imperial College NHS Healthcare Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients referred to the diabetic foot clinics at these sites will be asked to take part in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 hour; all tests will be performed on the same day of presentation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Investigators

  • Principal Investigator: Jaffer Usman, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

October 18, 2019

Study Completion (Actual)

October 18, 2019

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17HH4091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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