Clinical trial NCT04058626: TEsting for Arterial Disease in Diabetes (TrEAD) Study
Official title: Comparative Diagnostic Accuracy Study of Bedside Tests Used to Detect Arterial Disease in Diabetes:
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Peripheral Arterial Disease
Diabetic Foot Ulcer
Peripheral Vascular Diseases
Peripheral Artery Disease
Critical Limb Ischemia
Critical Lower Limb Ischemia
Keywords: Peripheral Vascular Diseases
Diabetic Foot
Critical Limb Ischemia
Diagnosis
Peripheral arterial disease
Diabetic foot ulcer
Duplex ultrasound
Ultrasound
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: 1 hour; all tests will be performed on the same day of presentation.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: West Middlesex University Hospital
city: London
country: United Kingdom
facility: Imperial College NHS Healthcare Trust
Study officials:
affiliation: Imperial College London
name: Jaffer Usman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Normahani P, Poushpas S, Alaa M, Bravis V, Aslam M, Jaffer U. Study protocol for a comparative diagnostic accuracy study of bedside tests used to detect arterial disease in diabetes: TEsting for Arterial disease in Diabetes (TrEAD) study. BMJ Open. 2020 Feb 5;10(2):e033753. doi: 10.1136/bmjopen-2019-033753.