Diagnostic accuracy of the maximal systolic acceleration for detection of peripheral arterial disease in patients with diabetes-related foot ulceration.

According to the latest 2021 data from the International Diabetes Federation,
an estimated 537 million adults are living with DM globally. Prevalence is
increasing rapidly, with numbers projected to rise to 643 million by 2030 and
783 million by 2045. Annually, DM causes 6.7 million deaths, as a consequence
of both macrovascular- (atherosclerosis) and microvascular disease
(retinopathy, nephropathy, and neuropathy).

Peripheral arterial disease (PAD) of the lower extremity is a clinical
manifestation of systemic atherosclerosis and considered a well-known
(long-term) complication of DM. Besides atherosclerosis, calcification of the
tunica media of the arterial wall can occur. This process is called medial
arterial calcification (MAC) and is accelerated in the presence of DM. Research
suggests that MAC is present in approximately one third of patients with DM.
MAC has been shown to be an independent predictor of cardiovascular mortality,
while another study found that patients with DM and PAD have an impaired
quality of life and an increased risk of adverse cardiac and limb events.

Timely recognition of limb ischemia is important in patients with DM/MAC in
order to reduce delayed wound healing, prevent lower limb amputation and
eventually reduce mortality. Current non-invasive bedside tests - such as the
ankle-brachial index (ABI) and toe pressure (TP) - are considered accurate for
the diagnosis of PAD. However, as shown in previous systematic reviews, the
performance of current bedside tests is not reliable in excluding PAD in
diabetic patients. The methodological quality of the studies in these reviews
were poor. In general, most of the data was collected retrospectively and not
all patients received reference testing. In order to assess the reliability of
bedside tests in this patient group, more well-sound methodological research is
required. Also alternative bedside tests need to be investigated.

The doppler derived maximal systolic acceleration (ACCmax) is a new
non-invasive parameter, which could be promising in detecting PAD. Although
ACCmax has already been used for renal artery stenosis, thorough evaluation has
not been performed in PAD. Two previous studies showed accurate diagnostic
property in diabetic patients, but the sample sizes were small.

The aim of this study is to assess the clinical value of bedside tests compared
to DUS to detect PAD in patients with diabetes-related foot ulceration, with
special emphasis on the ACCmax.

Comparative diagnostic accuracy study, prospectively enrolled.

- More elaborate diagnostic tests during first visit (approximately 30 minutes
more)
- No burden or risks, since all tests are non-invasive and are harmless