NCT04058626

TEsting for Arterial Disease in Diabetes (TrEAD) Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 305 (actual)
• Sponsor: Imperial College Healthcare NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-10-18
• Completion: 2019-10-18
• First posted: 2019-08-15
• Last updated: 2021-09-02
• Results posted: 2021-09-02

Locations

2 sites across 1 country: United Kingdom