DIAMACC: protocol of a prospective diagnostic accuracy study of the maximal systolic acceleration to detect peripheral arterial disease in patients with diabetes-related foot ulceration in the Netherlands.

introductionFoot ulcers are one of the most serious complications of diabetes, leading to significant risks on amputation and mortality. Peripheral arterial disease (PAD) is an important factor for the development and the outcome of diabetic foot ulcers (DFU). Although prompt and accurate detection of PAD is critical to reduce complications, its diagnosis can be challenging with currently used bedside tests (such as ankle-brachial index and toe pressure) due to medial arterial calcification. A new and promising bedside test for the detection of PAD is the maximal systolic acceleration (ACC METHODS AND ANALYSIS: A multicentre prospective diagnostic accuracy study with 198 patients will be conducted to assess the diagnostic performance of multiple index tests to detect PAD in patients with DFU, with special emphasis on ACC ETHICS AND DISSEMINATION: Study protocol approval was gained from the Medical Ethical Committee Leiden/Den Haag/Delft and registered at ClinicalTrials.gov. The findings of this study will be reported through peer-reviewed publications and (inter)national conferences. TRIAL REGISTRATION NUMBER: NCT05646147.