TEsting for Arterial Disease in Diabetes (TrEAD) Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

305 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-04

Study Completion Date

2019-10-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Foot Peripheral Arterial Disease Diabetic Foot Ulcer Peripheral Vascular Diseases Peripheral Artery Disease Critical Limb Ischemia Critical Lower Limb Ischemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Transcutaneous pressure of oxygen (TcPO2)

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