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Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial.

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.

SUBMITTER: Mirpour S

PROVIDER: S-EPMC7319950 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial.

Mirpour Shahriar S Fathollah Sara S Mansouri Parvin P Larijani Bagher B Larijani Bagher B Ghoranneviss Mahmood M Mohajeri Tehrani Mohammadreza M Amini Mohammad Reza MR

Scientific reports 20200626 1

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 ...[more]

PMID: 32591594

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Project description:ImportanceDiabetic foot ulcers are a common complication of diabetes and require specialized treatment. Cold atmospheric plasma (CAP) has been associated with benefits in wound infection and healing in previous smaller series of case reports. Yet the effect of CAP compared with standard care therapy in wound healing in diabetic foot ulcers remains to be studied.ObjectiveTo determine whether the application of CAP accelerates wound healing in diabetic foot ulcers compared with standard care therapy.Design, setting, and participantsA prospective, randomized, placebo-controlled, patient-blinded clinical trial was conducted at 2 clinics with recruitment from August 17, 2016, to April 20, 2019. Patients were scheduled to remain in follow-up until April 30, 2024. Patients with diabetes and diabetic foot ulcers described using the combined Wagner-Armstrong classification of 1B or 2B (superficial or infected diabetic foot ulcers extending to tendon) were eligible. A patient could participate with 1 or more wounds in both groups in both intervention and control groups. Wounds were randomized separately, allowing a participant to be treated several times within the study following a 2 × 2 × 2 randomization strata considering sex, smoking status, and age (≤68 years and >68 years).InterventionsStandard care treatment with 8 applications of either CAP generated from argon gas in an atmospheric pressure plasma jet or 8 applications of placebo treatment in a patient-blinded manner.Main outcomes and measuresPrimary end points were reduction in wound size, clinical infection, and microbial load compared with treatment start. Secondary end points were time to relevant wound reduction (>10%), reduction of infection, parameters of patient's well-being, and treatment-associated adverse events.ResultsOf 65 diabetic foot ulcer wounds from 45 patients assessed for study, 33 wounds from 29 patients were randomized to CAP and 32 wounds from 28 to placebo, with 62 wounds from 43 patients (31 wounds per group) included for final evaluation (mean [SD] age, 68.5 [9.1] years for full sample). 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 (SD) area reduction (CAP vs placebo relative units, -26.31 [11.72]; P = .03) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]; P = .009). Reduction of infection and microbial load was not significantly different between CAP and placebo. No therapy-related adverse events occurred during therapy; patient's perceptions during therapy were comparable.Conclusions and relevanceIn this randomized clinical trial, CAP therapy resulted in beneficial effects in chronic wound treatment in terms of wound surface reduction and time to wound closure independent from background infection.Trial registrationClinicalTrials.gov Identifier: NCT04205942.

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Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial.

Publications

Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial.

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