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Abstract
Cold atmospheric plasma (CAP) was shown to decrease bacterial load in chronic wounds. It was also presented as a novel approach to healing wounds in both in vitro and in vivo experiments. We aimed to examine the first randomized clinical trial for the use of CAP in diabetic foot ulcers. Patients (n = 44) were randomly double-blinded, and assigned to receive standard care (SC, n = 22) without or with CAP, to be applied three times a week for three consecutive weeks (SC + CAP, n = 22), using block randomization with mixing block sizes of four. The trial was conducted at the Diabetes Research Center in Tehran, Iran. CAP was generated from ionized helium gas in ambient air, and driven by a high voltage (10 kV) and high frequency (6 kHz) power supply. Primary outcomes were wound size, number of cases reaching wound size of <0.5, and a bacterial load after over three weeks of treatment. CAP treatment effectively reduced the fraction of wound size (p = 0.02). After three weeks, the wounds to reach fraction wound size of ≤0.5 was significantly greater in the SC + CAP group (77.3%) compared to the SC group (36.4%) (p = 0.006). The mean fraction of bacterial load counted in each session ‘after CAP exposure’ was significantly less than ‘before exposure’ measures. CAP can be an efficient method to accelerate wound healing in diabetic foot ulcers, with immediate antiseptic effects that do not seem to last long.
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1 Department of Applied physics, Eindhoven university of Technology, Eindhoven, The Netherlands (GRID:grid.6852.9) (ISNI:0000 0004 0398 8763)
2 Department of Applied physics, Amirkabir university of Technology, Tehran, Iran (GRID:grid.411368.9) (ISNI:0000 0004 0611 6995)
3 Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran (GRID:grid.411705.6) (ISNI:0000 0001 0166 0922)
4 Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran (GRID:grid.411705.6) (ISNI:0000 0001 0166 0922)
5 Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran (GRID:grid.411705.6) (ISNI:0000 0001 0166 0922)