TEsting for Arterial Disease in Diabetes (TrEAD) Study

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Diagnostic Test: Transcutaneous pressure of oxygen (TcPO2)
* Diagnostic Test: Toe Brachial Pressure Index (TBPI)
* Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan)
* Diagnostic Test: Duplex Assist
* Diagnostic Test: Ankle Brachial Pressure Index (ABPI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transcutaneous pressure of oxygen (TcPO2)|Measurements will be taken from the dorsum of the foot using an automated machine equipped with Clark electrodes.|
|Diagnostic Test: Toe Brachial Pressure Index (TBPI)|TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.|
|Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan)|Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.|
|Diagnostic Test: Duplex Assist|Continuous Doppler device which gives visual display of arterial spectral waveform at the ankle.|
|Diagnostic Test: Ankle Brachial Pressure Index (ABPI)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Vascular Diseases, Diabetic Foot, Critical Limb Ischemia, Diagnosis, Peripheral arterial disease, Diabetic foot ulcer, Duplex ultrasound, Ultrasound