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

INTRODUCTION: In the UK, over 7000 amputations are performed each year because of diabetes. Up to 80% of these are preceded by a foot ulcer and could therefore be prevented with improvements in ulcer care. Peripheral arterial disease is an important risk factor for the development of diabetic foot ulceration. However, its diagnosis in diabetes is challenging due to the presence of neuropathy and arterial calcification. Commonly used bedside tests either have low sensitivities or little supporting evidence to justify their use. Duplex ultrasound (DUS) has good correlation to angiography findings but a full scan is difficult to learn and time consuming to perform. We have previously demonstrated that a focused DUS of the distal anterior and posterior tibial arteries at the ankle (podiatry ankle duplex scan (PAD-scan)) can be readily learnt by novices and performed rapidly and accurately. The primary aim of this study is to determine the diagnostic accuracy of the PAD-scan and other commonly used bedside tests in detecting arterial disease in diabetes. METHODS AND ANALYSIS: The study will include 305 patients presenting to diabetic foot clinics at two centres. Arterial assessment will be performed using the following index tests: the PAD-scan, pulse palpation, audible handheld Doppler, Ankle Brachial Pressure Index, Toe Brachial Pressure Index and transcutaneous pressure of oxygen. Patients will then undergo a full lower limb arterial DUS by a blinded vascular scientist as a reference test. ETHICS AND DISSEMINATION: Approval was gained from NRES Committee London (REC reference 17/LO/1447). Findings will be disseminated by various methods including international presentations and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04058626).