Diabetes Limb Salvage Service, Leeds Teaching Hospitals NHS Trust, Leeds, U.K.
Leeds Institute of Cardiovascular and Metabolic Medicine, School of Medicine, University of Leeds, Leeds, U.K.
Diabetes Care. 2022 Jul 7;45(7):1601-1609. doi: 10.2337/dc21-2218.
To estimate comparative healing rates and decision-making associated with the use of bacterial autofluorescence imaging in the management of diabetic foot ulcers (DFUs).
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.
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.
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.
评估细菌自体荧光成像在糖尿病足溃疡（DFU）管理中的比较愈合率和决策相关因素。
这是一项单中心（多学科门诊）、前瞻性、随机对照试验（RCT），纳入了活动性 DFU 且无疑似临床感染的患者。同意参加的患者按 1:1 随机分配至接受自体荧光成像指导的常规治疗（干预组）或仅接受常规治疗（对照组）。主要结局是 12 周时通过盲法评估的溃疡愈合比例。次要结局包括 4 周和 12 周时的创面面积缩小、患者生活质量以及自体荧光成像后管理决策的变化。
2017 年 11 月至 2019 年 11 月，56 例患者被随机分配至对照组或干预组。自体荧光组 12 周时溃疡愈合的比例为 45%（n=29 例中的 13 例），对照组为 22%（n=27 例中的 6 例）。4 周时创面面积缩小 40.4%（自体荧光），对照组为 38.6%；12 周时缩小 91.3%（自体荧光），对照组为 72.8%。自体荧光成像阳性的创面最常见的干预措施是清创。愈合方面存在一个逐步的趋势，倾向于自体荧光成像阴性的患者，其次是自体荧光成像阳性但接受干预的患者，最后是自体荧光成像阳性且无干预的患者。
在我们所知的第一项评估自体荧光成像在 DFU 管理中应用的 RCT 中，我们的结果表明，进行一项有足够效力的 RCT 是可行和合理的。在 DFU 管理中，自体荧光成像可能除了标准治疗之外还有价值。
