Cold atmospheric pressure plasma as a novel treatment modality in diabetic foot ulcers: a pilot study

Edgar J. Peters, Rimke Lagrand, Paulien Smits, A. Pemen, Ana Sobota, Bas Zeper, Louise W. Sabelis

Onderzoeksoutput: Bijdrage aan tijdschriftMeeting AbstractAcademic

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Introduction: Antimicrobial resistance is a growing problem in the treatment of diabetic foot ulcers. Plasma devices generate an ionized gas with a cocktail of highly reactive species, electric fields and UV light. Cold atmospheric plasma (CAP) treatment has advantages over antiseptic or antimicrobial infection prevention and control; it disinfects efficiently, painlessly and instantly, without development of antimicrobial resistance. Concurrently, plasma can stimulate human cell proliferation and migration as well as microcirculation. We studied the safety of a novel CAP device, that is simple to use and in the future can be applied at a patient’s home.

Method: We included subjects with diabetic foot ulcers (maximum depth 5 millimeters) without clinical signs of infection or exposed bone or joint in the wound base. Subjects were treated with CAP on a daily basis for ten days in a two-week period. Primary endpoint of this study was the occurrence of serious adverse events (SAE) as a result of treatment. Safety was defined as ≤ 10% of subjects experiencing SAE related to treatment other than infection, and ≤ 60% of subjects developing infection within 30 days after treatment. Standard protocols for wound treatment were deployed, including weekly debridement and offloading.

Results: Twenty subjects were enrolled. Three SAEs (infections) occurred at the site of application within one month of treatment, of which one occurred during treatment. Three SAEs unrelated to treatment occurred: pneumonia, toe amputation on the contralateral foot and a soft tissue infection of the ipsilateral leg. Transient adverse events (AE grade 1) during one or more applications were reported by 53% of subjects.

Discussion: No SAE other than infection occurred as a result of treatment and ≤ 60% of subjects developed an infection. The AEs were low graded and transient. The results of our study demonstrate that the application of CAP in diabetic foot ulcers is safe.
Originele taal-2Engels
Artikelnummer44-LB
Pagina's (van-tot)LB12
Aantal pagina's1
TijdschriftDiabetes
Volume67
DOI's
StatusGepubliceerd - 1 jul 2018

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