Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Internal Medicine, Amsterdam Movement Sciences, Amsterdam, Netherlands.
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, De Boelelaan 1117, 1081 HV Amsterdam, Netherlands.
J Wound Care. 2023 Apr 2;32(4):247-251. doi: 10.12968/jowc.2023.32.4.247.
Cold atmospheric plasma (CAP) has antimicrobial properties. We studied the safety of a novel CAP device (PLASOMA prototype; Plasmacure, The Netherlands) that is simple to use and could be applied at a patient's home for the treatment of diabetic foot ulcers (DFUs). Secondary objectives were to investigate the effect of CAP on bacterial load and on ulcer size.
We included subjects with non-infected, superficial DFUs and treated them with CAP on a daily basis for 10 days. The primary endpoint was the occurrence of serious adverse device effects (SADE). We defined safety as: ≤10% of patients experiencing a SADE other than infection (non-infectious SADE), and ≤60% of patients developing infection of the foot (infectious serious adverse event (SAE)).
We enrolled 20 patients. No SADE occurred, but three infectious SAEs occurred at the site of application within one month of treatment; three SAEs unrelated to treatment occurred, and 55% of subjects reported transient mild adverse device effects. bacterial load decreased directly after CAP application (p=0.01). The mean decrease of ulcer surface area was 43% (95% confidence interval: 20.2%-65.9%).
CAP treatment in DFUs was safe and well tolerated. Ulcer size and colonisation decreased during treatment.
冷大气压等离子体（CAP）具有抗菌特性。我们研究了一种新型 CAP 设备（PLASOMA 原型；Plasmacure，荷兰）的安全性，该设备使用简单，可以在患者家中应用于治疗糖尿病足溃疡（DFU）。次要目标是研究 CAP 对细菌负荷和溃疡大小的影响。
我们纳入了非感染性、浅表性 DFU 患者，并每天用 CAP 治疗 10 天。主要终点是严重不良设备事件（SADE）的发生。我们将安全性定义为：≤10%的患者出现除感染以外的 SAE（非感染性 SAE），≤60%的患者足部发生感染（感染性严重不良事件（SAE））。
我们共纳入 20 例患者。未发生 SAE，但治疗后 1 个月内治疗部位出现 3 例感染性 SAE；发生 3 例与治疗无关的 SAE，55%的患者报告短暂轻度不良设备效应。CAP 应用后细菌负荷直接下降（p=0.01）。溃疡表面积的平均减少率为 43%（95%置信区间：20.2%-65.9%）。
DFU 中 CAP 治疗安全且耐受良好。治疗过程中溃疡大小和定植减少。
