OBJECTIVE To estimate comparative healing rates and decision-making associated with the use of bacterial autofluorescence imaging in the management of diabetic foot ulcers (DFUs). RESEARCH DESIGN AND METHODS This is a single-center (multidisciplinary outpatient clinic), prospective pilot, randomized controlled trial (RCT) in patients with an active DFU and no suspected clinical infection. Consenting patients were randomly assigned 1:1 to either treatment as usual informed by autofluorescence imaging (intervention), or treatment as usual alone (control). The primary outcome was the proportion of ulcers healed at 12 weeks by blinded assessment. Secondary outcomes included wound area reduction at 4 and 12 weeks, patient quality of life, and change in management decisions after autofluorescence imaging. RESULTS Between November 2017 and November 2019, 56 patients were randomly assigned to the control or intervention group. The proportion of ulcers healed at 12 weeks in the autofluorescence arm was 45% (n = 13 of 29) vs. 22% (n = 6 of 27) in the control arm. Wound area reduction was 40.4% (autofluorescence) vs. 38.6% (control) at 4 weeks and 91.3% (autofluorescence) vs. 72.8% (control) at 12 weeks. Wound debridement was the most common intervention in wounds with positive autofluorescence imaging. There was a stepwise trend in healing favoring those with negative autofluorescence imaging, followed by those with positive autofluorescence who had intervention, and finally those with positive autofluorescence with no intervention. CONCLUSIONS In the first RCT, to our knowledge, assessing the use of autofluorescence imaging in DFU management, our results suggest that a powered RCT is feasible and justified. Autofluorescence may be valuable in addition to standard care in the management of DFU.

中文翻译：

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护理点细菌自发荧光成像在糖尿病足溃疡治疗中的应用：一项随机对照试验

目的 评估与使用细菌自发荧光成像治疗糖尿病足溃疡 (DFU) 相关的比较治愈率和决策。研究设计和方法 这是一项单中心（多学科门诊）、前瞻性试点、随机对照试验 (RCT)，对象是活动性 DFU 且无疑似临床感染的患者。同意的患者按照 1:1 的比例随机分配到照常进行自发荧光成像治疗（干预）或照常单独治疗（对照）。主要结果是通过盲法评估，12 周时溃疡愈合的比例。次要结局包括第 4 周和第 12 周时伤口面积的减少、患者的生活质量以及自发荧光成像后管理决策的变化。结果 2017年11月至2019年11月期间，56名患者被随机分配到对照组或干预组。12 周时，自发荧光组中溃疡愈合的比例为 45%（n = 29 人中的 13 人），而对照组为 22%（n = 27 人中的 6 人）。4 周时，伤口面积减少 40.4%（自发荧光），对比 38.6%（对照）；12 周时，伤口面积减少 91.3%（自发荧光），对比 72.8%（对照）。伤口清创是对自发荧光成像呈阳性的伤口最常见的干预措施。愈合呈逐步趋势，有利于自发荧光成像阴性的患者，其次是接受干预的自发荧光阳性的患者，最后是未干预的自发荧光阳性的患者。结论 据我们所知，在第一个随机对照试验中，评估了自发荧光成像在 DFU 管理中的使用，我们的结果表明动力随机对照试验是可行且合理的。除了标准护理之外，自发荧光在糖尿病足溃疡的治疗中可能也很有价值。