NCT04058626

TEsting for Arterial Disease in Diabetes (TrEAD) Study

Completed Results posted Last updated 2 September 2021

What this trial tests

trial testing Transcutaneous pressure of oxygen (TcPO2) in Diabetic Foot in 305 participants. Completed in 18 October 2019.

Timeline

4 March 2019

Primary endpoint
18 October 2019

18 October 2019

Quick facts

Lead sponsor	Imperial College Healthcare NHS Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	305
Start date	4 March 2019
Primary completion	18 October 2019
Estimated completion	18 October 2019
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Transcutaneous pressure of oxygen (TcPO2)
• Toe Brachial Pressure Index (TBPI)
• Podiatry Ankle Duplex scan (PAD-scan)
• Duplex Assist
• Ankle Brachial Pressure Index (ABPI)

Conditions studied

• Diabetic Foot — all drugs for Diabetic Foot →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
• Peripheral Vascular Diseases — all drugs for Peripheral Vascular Diseases →

Sponsor

Imperial College Healthcare NHS Trust

Who can join

18 and older, any sex, with Diabetic Foot or Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnostic Accuracy Primary · 1 hour; all tests will be performed on the same day of presentation.

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).

PAD-scan sensitivity

Group	Value	95% CI
Study Participants	95	90 – 97

PAD-scan specificity

Group	Value	95% CI
Study Participants	77	67 – 84

TBPI sensitivity

Group	Value	95% CI
Study Participants	60	51 – 68

TBPI specificity

Group	Value	95% CI
Study Participants	86	77 – 92

Pulse sensitivity

Group	Value	95% CI
Study Participants	43	36 – 50

Pulse specificity

Group	Value	95% CI
Study Participants	81	72 – 88

Doppler (audible) sensitivity

Group	Value	95% CI
Study Participants	74	67 – 80

Doppler (audible) specificity

Group	Value	95% CI
Study Participants	76	66 – 84

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Normahani P, Poushpas S, Alaa M, Bravis V, et al · · 2020 · cited 11× · PMID 32029491 · DOI 10.1136/bmjopen-2019-033753
2. Evaluating the prognostic performance of bedside tests used for peripheral arterial disease diagnosis in the prediction of diabetic foot ulcer healing.
   Elghazaly H, Howard T, Sanjay S, Mohamed OG, et al · · 2023 · cited 7× · PMID 36918215 · DOI 10.1136/bmjdrc-2022-003110