Cold atmospheric plasma may improve healing of diabetic ulcers: JAMA
Germany: Application of cold atmospheric plasma (CAP) may improve wound healing in patients with diabetic foot ulcers (DFU), a recent study in the journal JAMA has revealed. This may lead to earlier discharge from the hospital and transition to ambulatory treatment.
DFU is a common complication experienced by diabetes patients that require specialized treatment. In the previous smaller series of case reports, CAP has been associated with benefits in healing and wound infection. Yet, no study has been performed to compare the effect of CAP with standard care therapy for wound healing in diabetic foot ulcers.
Bernd Stratmann, Ruhr Universität Bochum, Bad Oeynhausen, Germany, and colleagues determined whether CAP application accelerates wound healing in diabetic foot ulcers compared with standard care therapy.
For the purpose, they conducted a prospective, randomized, placebo-controlled, patient-blinded clinical trial at 2 clinics with recruitment August 17, 2016, to April 20, 2019. The patients were scheduled to remain in follow-up until April 30, 2024. It included 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 the tendon). 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).
The patients were randomized to 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.
The primary endpoints were a reduction in wound size, clinical infection, and microbial load compared with treatment start.
Key findings of the study include:
- 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]) and mean (SD) time to relevant wound area reduction (CAP vs placebo relative units, 10% from baseline, 1.60 [0.58]).
- 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.
"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," concluded the authors.
DOI: 10.1001/jamanetworkopen.2020.10411
