Section of Vascular Surgery, Imperial College London, London, UK
Imperial Vascular Unit, Imperial College NHS Healthcare Trust, London, UK.
BMJ Open Diabetes Res Care. 2023 Mar;11(2). doi: 10.1136/bmjdrc-2022-003110.
Diabetic foot ulceration (DFU) is a common and challenging complication of diabetes. Risk stratification can guide further management. We aim to evaluate the prognostic performance of bedside tests used for peripheral arterial disease (PAD) diagnosis to predict DFU healing.
Testing for Arterial Disease in Diabetes (TrEAD) was a prospective observational study comparing the diagnostic performance of commonly used tests for PAD diagnosis. We performed a secondary analysis assessing whether these could predict DFU healing. Follow-up was performed prospectively for 12 months. The primary outcome was sensitivity for predicting ulcer healing. Secondary endpoints were specificity, predictive values, and likelihood ratios for ulcer healing.
123 of TrEAD participants with DFU were included. In 12 months, 52.8% of ulcers healed. The best negative diagnostic likelihood ratio (NDLR) was observed for the podiatry ankle duplex scan (PAD-scan) monophasic or biphasic with adverse features(NDLR 0.35, 95% CI 0.14-0.90). The highest positive likelihood ratios were observed for toe brachial pressure index of ≤0.2 (positive diagnostic likelihood ratio (PDLR) 7.67, 95% CI 0.91-64.84) and transcutaneous pressure of oxygen of ≤20 mm Hg (PDLR 2.68, 95% CI 0.54-13.25). Cox proportional hazards modeling demonstrated significantly greater probabilities of healing with triphasic waveforms (HR=2.54, 95% CI 1.23-5.3, p=0.012) and biphasic waveforms with non-adverse features (HR=13.67, 95% CI 4.78-39.1, p<0.001) on PAD-scan.
No single test performed well enough to be used in isolation as a prognostic marker for the prediction of DFU healing.
NCT04058626.
糖尿病足溃疡（DFU）是糖尿病常见且具有挑战性的并发症。风险分层可指导进一步的管理。我们旨在评估用于诊断外周动脉疾病（PAD）的床边检测对预测 DFU 愈合的预后性能。
糖尿病动脉疾病检测（TrEAD）是一项前瞻性观察性研究，比较了常用于 PAD 诊断的检测的诊断性能。我们进行了二次分析，评估这些检测是否可以预测 DFU 愈合。前瞻性随访 12 个月。主要结局是预测溃疡愈合的敏感性。次要结局是特异性、预测值和溃疡愈合的似然比。
TrEAD 中共有 123 名 DFU 参与者。在 12 个月时，52.8%的溃疡愈合。观察到最差的阴性诊断似然比（NDLR）是在足部科踝部双功超声扫描（PAD-scan）单相或双相且具有不良特征时（NDLR 0.35，95%CI 0.14-0.90）。最高的阳性似然比见于趾肱压力指数≤0.2（阳性诊断似然比（PDLR）7.67，95%CI 0.91-64.84）和经皮氧分压≤20mmHg（PDLR 2.68，95%CI 0.54-13.25）。Cox 比例风险模型表明，在 PAD-scan 中，具有三相波的溃疡具有更高的愈合概率（HR=2.54，95%CI 1.23-5.3，p=0.012），且具有非不良特征的双相波（HR=13.67，95%CI 4.78-39.1，p<0.001）。
没有单一的检测结果足够好，可以单独用作预测 DFU 愈合的预后标志物。
NCT04058626。
