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

Importance: Diabetic 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. Objective: To determine whether the application of CAP accelerates wound healing in diabetic foot ulcers compared with standard care therapy. Design, Setting, and Participants: A 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). Interventions: Standard 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 Measures: Primary 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. Results: Of 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 Relevance: In 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 Registration: ClinicalTrials.gov Identifier: NCT04205942.

Psychometric properties of the Calgary Cambridge guides to assess communication skills of undergraduate medical students.

OBJECTIVE: The aim of this study was to analyse the psychometric properties of the short version of the Calgary Cambridge Guides and to decide whether it can be recommended for use in the assessment of communications skills in young undergraduate medical students. METHODS: Using a translated version of the Guide, 30 members from the Department of General Practice rated 5 videotaped encounters between students and simulated patients twice. Item analysis should detect possible floor and/or ceiling effects. The construct validity was investigated using exploratory factor analysis. Intra-rater reliability was measured in an interval of 3 months, inter-rater reliability was assessed by the intraclass correlation coefficient. RESULTS: The score distribution of the items showed no ceiling or floor effects. Four of the five factors extracted from the factor analysis represented important constructs of doctor-patient communication The ratings for the first and second round of assessing the videos correlated at 0.75 (p<0.0001). Intraclass correlation coefficients for each item ranged were moderate and ranged from 0.05 to 0.57. CONCLUSIONS: Reasonable score distributions of most items without ceiling or floor effects as well as a good test-retest reliability and construct validity recommend the C-CG as an instrument for assessing communication skills in undergraduate medical students. Some deficiencies in inter-rater reliability are a clear indication that raters need a thorough instruction before using the C-CG.

A case of Legionnaires' disease caused by aspiration of ice water.

The authors discuss the case of a 79-year-old patient who suffered from a swallowing disorder and developed Legionnaires' disease 2 days after her dismissal from an orthopedics ward, where she had recovered from hip surgery. To determine the source of the Legionnaires' disease, the authors performed an environmental investigation, which included a national, standardized questionnaire and a microbiological investigation of suspected sources. The investigation revealed ice from an ice-making machine in the hospital as the most probable source of the infection through aspiration, even though the hospital had rigorously adhered to strict assessment and decontamination schedules. The infectious serogroup was one that was not common to the area. From the data available, the authors inferred that a dose of 1-2000 colony-forming units might have caused Legionnaires' disease in this patient.