TEsting for Arterial Disease in Diabetes (TrEAD) Study

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058626
• Other study ID #: 17HH4091
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: October 18, 2019

Study information

• Verified date: September 2021
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• Duplex Assist
Continuous Doppler device which gives visual display of arterial spectral waveform at the ankle.
• 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.

Locations

Country	Name	City	State
United Kingdom	Imperial College NHS Healthcare Trust	London
United Kingdom	West Middlesex University Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.