Effect of Cold Atmospheric Plasma Therapy vs Standard Therapy Placebo on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial

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Main idea: In this randomized clinical trial, Cold atmospheric plasma therapy resulted in beneficial effects in chronic wound treatment in terms of wound surface reduction and time to wound closure independent from background infection.

Abstract

Importance: Diabetic foot ulcers are a common complication of diabetes and require specialized treatment. Cold atmospheric plasma has been associated with benefits in wound infection and healing in previous smaller series of case reports. Yet the effect of   compared with standard care therapy in wound healing in diabetic foot ulcers remains to be studied.

The main objective is to determine whether the application of Cold atmospheric plasma accelerates wound healing in diabetic foot ulcers compared with standard care therapy.

Results: Of 65 diabetic foot ulcer wounds from 45 patients assessed for study, 33 wounds from 29 patients were randomized to Cold atmospheric plasma and 32 wounds from 28 to placebo, with 62 wounds from 43 patients (31 wounds per group) included for final evaluation. Four patients with 5 wounds of 31 (16.1%) wounds in the CAP group and 3 patients with 4 wounds of 31 (13%) wounds in the placebo group were active smokers. CAP therapy yielded a significant increase in wound healing, both in total mean area reduction . Reduction of infection and microbial load was not significantly different between Cold atmospheric plasma and placebo. No therapy-related adverse events occurred during therapy; patient’s perceptions during therapy were comparable.

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