نبذة مختصرة : 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.
Processing Request
No Comments.