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.
E.J. Peters: None. R. Lagrand: None. P. Smits: Employee; Self; Plasmacure BV. A. Pemen: None. A. Sobota: None. B. Zeper: Stock/Shareholder; Self; Plasmacure. L.W. Sabelis: None.
