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临床试验/NCT05646147
NCT05646147Unknown不适用

Diagnostic Accuracy of the Maximal Systolic Acceleration for Detection of Peripheral Arterial

Leiden University Medical Center0 个研究点目标入组 238 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
238
主要终点
Reliability of standard bedside tests and the maximal systolic acceleration (ACCmax)

研究概览

简要总结

Prevalence of diabetes mellitus (DM) is increasing rapidly, with patient numbers projected to rise to 643 million by 2030. As a consequence of diabetes-related atherosclerosis, peripheral arterial disease (PAD) and in particular medial arterial calcification (MAC) can occur. The accurate identification of PAD by bedside tests is extremely important in patients with diabetes and foot ulceration, in order to reduce delayed wound healing, prevent lower limb amputation and eventually reduce mortality. However, as shown in previous systematic reviews, the performance of current bedside tests is not reliable in excluding PAD in diabetic patients.1,2 Moreover, the methodological quality of the conducted studies is generally poor. Therefore, more reliable and prospective data is required. Also alternative bedside tests need to be investigated. As an example, the ACCmax (a new doppler derived parameter) could be particularly promising in this patient group.

详细描述

According to the latest 2021 data from the International Diabetes Federation, an estimated 537 million adults are living with DM globally.3 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). In 2021, diabetes caused at least 966 billion dollars in health expenditure, comprising approximately 9% of total spending on adults. Type 2 diabetes comprises about 85-90% of these cases, in which disease onset is often insidious, and diagnosis is consequently delayed.4

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.5 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.6,7

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.8 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.1,2 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 stenosis9, thorough evaluation has not been performed in PAD. Two previous studies showed accurate diagnostic property in diabetic patients, but the sample sizes were small.10,11

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older.
  • DM in medical history.
  • Presenting with a new-onset wound or ulceration on the foot or ankle with initiation of a new diagnostic care path.

排除标准

  • - Lacking capacity to consent for inclusion.

结局指标

主要结局

Reliability of standard bedside tests and the maximal systolic acceleration (ACCmax)

时间窗: Through study completion, approximately 1.5 years

Sensitivity and specificity including their derivates: PLR and NLR

次要结局

  • Comparison of patient demographics (such as age/sex) and comorbidities (duration of diabetes, chronic kidney disease) with diagnostic accuracy of different bedside tests(Through study completion, approximately 1.5 years)
  • Wound healing and ACCmax(Up to 5 years after study completion)
  • Comparison of ACCmax reliability with current bedside tests(Through study completion, approximately 1.5 years)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

jjwmbrouwers

Surgical Resident, MD, PhD-candidate, post-doc

Leiden University Medical Center

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