Cold atmospheric pressure plasma for accelerated wound healing in diabetic foot: the prospective, randomised, placebo-controlled KPW-Trial

Diabetic foot is a common complication of diabetes mellitus and requires specialized treatment. Cold plasma has demonstrated beneficial effects on wound infection and healing in case reports. The “Kaltplasma Wund (KPW)-Trial” aimed to analyse whether the application of cold plasma accelerates wound healing in diabetic foot compared to standard care therapy. It was a prospective, randomized, placebo-controlled, patient-blinded, bi-center trial. People with diabetes mellitus and diabetic foot WA 1B or 2B were eligible. Each wound was randomized separately. Wounds were treated additionally with cold plasma generated from inert argon gas in an atmospheric pressure plasma jet or placebo. Primary endpoints were reduction in wound size, in clinical infection and microbial load compared to beginning. Important secondary endpoints were time to significant wound reduction (>10%), and to reduction of infection. Ad hoc we analysed the time to 20% wound reduction. In addition, wound dressings from 15 patients per group were analysed for expression of VEGF via ELISA. In total 65 cases were included in the study and 62 were considerable for final evaluation. Plasma therapy yielded in a significant increase of wound healing, both in total area reduction (-26.31±11.72, p=0.0248 vs. placebo) as well as time to significant wound area reduction (10% from baseline, -1.60±0.58, p=0.0085 vs. placebo). The effect was even more significant, if the reduction level was set to 20% (p<0.0001). Reduction of infection and microbial load was not significantly pronounced in plasma therapy. Regarding the expression of VEGF wounds in the plasma group presented throughout the study with at most visits significant higher levels of baseline corrected VEGF than wounds randomized to placebo therapy. Cold plasma therapy revealed beneficial effects in chronic wound treatment in terms of wound surface reduction and time to wound closure independent from background infection. Disclosure B. Stratmann: Speaker’s Bureau; Self; AstraZeneca, Neoplas Tools GmbH. T. Costea: Other Relationship; Self; Merck Sharp & Dohme Corp. C. Nolte: None. J. Hiller: None. J. Schmidt: None. J. Reindel: None. K. Masur: None. W.H. Motz: None. J. Timm: None. W. Kerner: None. D. Tschoepe: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH. Research Support; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Neoplas tools GmbH.