Vascular Surgery, Imperial College Healthcare NHS Trust, London, UK
Vascular Surgery, Imperial College Healthcare NHS Trust, London, UK.
BMJ Open. 2020 Feb 5;10(2):e033753. doi: 10.1136/bmjopen-2019-033753.
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.
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.
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.
ClinicalTrials.gov Registry (NCT04058626).
在英国，每年有超过 7000 例截肢是由于糖尿病引起的。其中多达 80%的截肢是由足部溃疡引起的，如果溃疡护理得到改善，这些溃疡是可以预防的。周围动脉疾病是糖尿病患者发生足部溃疡的一个重要危险因素。然而，由于存在神经病变和动脉钙化，其在糖尿病中的诊断具有挑战性。常用的床边检查要么敏感性低，要么缺乏支持其使用的证据。双功能超声（DUS）与血管造影结果相关性良好，但全面扫描难以学习且耗时。我们之前已经证明，通过踝关节（足病科踝部双功能超声扫描（PAD 扫描））的远端前、后胫骨动脉的焦点 DUS 可以由新手轻松学习，并快速、准确地进行。本研究的主要目的是确定 PAD 扫描和其他常用床边检查在检测糖尿病患者动脉疾病中的诊断准确性。
该研究将包括来自两个中心的 305 例糖尿病足诊所就诊患者。将使用以下指数检查进行动脉评估：PAD 扫描、脉搏触诊、手持式可听多普勒、踝肱压指数、趾肱压指数和经皮氧分压。然后，患者将接受一位盲法血管科医生进行的下肢动脉 DUS 检查作为参考检查。
已获得 NRES 委员会伦敦分会（REC 参考号 17/LO/1447）的批准。研究结果将通过各种方法进行传播，包括国际演讲和在同行评议期刊上发表。
ClinicalTrials.gov 注册（NCT04058626）。
