SerenaGroup Inc., Cambridge, MA, US.
Royal Research Corp., Pembroke Pines, FL, US.
J Wound Care. 2021 May 1;30(Sup5):S7-S14. doi: 10.12968/jowc.2021.30.Sup5.S7.
Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks).
This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events.
For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events.
This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.
由于血液循环不良、血管破裂和血管收缩，导致难以愈合的伤口的灌注和血氧水平经常不足，从而降低了伤口的愈合能力。本研究旨在探讨局部氧疗对治疗难以愈合的糖尿病足溃疡（DFU）（即 4 周以上无反应）患者的愈合率的影响。
这项多中心、开放性、社区为基础的随机临床试验比较了标准治疗（SOC）加或不加持续局部氧疗（TOT）12 周对 DFU 或小截肢伤口患者的治疗效果。SOC 包括清创、全接触加压包扎（TCC）和适当的水分平衡。主要终点是达到完全伤口闭合的患者数量和溃疡大小的百分比变化。次要终点是疼痛水平和不良事件。
在这项研究中，145 名患者被随机分为指数溃疡分级美国传染病学会（IDSA）1 级或 2 级，或 Wagner 1 级或 2 级。在意向治疗分析中，SOC 组在 12 周时有 18/64（28.1%）名患者愈合，SOC 加 TOT 组有 36/81（44.4%）名患者愈合（p=0.044）。两组之间的伤口面积有统计学显著的减少：SOC 组平均减少 40%（标准差 72.1）；SOC 加 TOT 组平均减少 70%（标准差 45.5）；按方案分析，p=0.005）。疼痛水平或不良事件的变化无显著差异。
本研究表明，SOC 加 TOT 有助于治疗难以愈合的 DFU 患者的伤口闭合。
