Diabetic foot ulcers occur in up to 10% of all diabetics during their lifetime. A randomized controlled trial has now shown that treatment with cold atmospheric plasma promotes the healing of diabetic ulcers.
A combined presence of neuropathy, microangiopathy, macroangiopathy, and foot deformities makes diabetic patients susceptible to ulcerations, which have a high risk of infection and heal poorly because of the diabetic metabolic condition. Diabetic foot syndrome is a common cause of amputations. There has long been evidence from case reports and laboratory studies that the use of cold atmospheric plasma can stimulate the healing process and thus contribute to faster wound closure. This effect has now been empirically proven in a clinical study by scientists at the Heart and Diabetes Center NRW, Bad Oeynhausen (D) in cooperation with Klinikum Karlsburg (D).
In this world’s first randomized, placebo-controlled, patient-blinded study of wound treatment using adjuvant cold plasma therapy, a total of 62 wounds in the setting of diabetic foot syndrome were studied in 43 hospitalized patients. The wounds with a severity of 1B and 2B according to the Wagner-Armstrong classification had not shown any healing tendencies for at least three weeks despite standard wound therapy in the outpatient setting. The kINPen® MED plasma jet from neoplas tools, which was developed jointly with the Leibniz Institute for Plasma Research and Technology e. V., was used as the cold plasma,
Significant reduction of the wound area
The primary endpoints of the study were the reduction in wound area after 14 days of treatment and the infection status and microbial load of the wounds. Secondary endpoints included time to ten percent wound closure, health-related quality of life, and safety and tolerability of treatment. After 14 days of treatment, the wound surface had reduced by a mean of 69.5% in wounds treated with cold plasma. In the placebo group, the reduction was 44.8%. The result is statistically significant.
Activation of the healing process and faster wound closure
Cold plasma treatment proved to be painless and well tolerated. No side effects associated with cold plasma therapy occurred until the completion of treatment. “In this study, we were able to demonstrate for the first time in a clinically controlled manner that cold plasma actively promotes wound healing,” says PD Dr. Bernd Stratmann, head of research at the Diabetes Center at the Heart and Diabetes Center NRW and first author of the study. “The results thus confirm previous findings from case studies. In contrast to the placebo group, healing progression was activated in all wounds treated with cold plasma – defined as at least a ten percent reduction in wound area. As a result, cold plasma treatment accelerated wound healing, leading to faster wound closure than standard treatment alone.” Patients will continue to be followed for five years to also evaluate the long-term safety of the treatment. The study results were published in the Journal of the American Medical Association.
Source: neoplas tools GmbH
Original publication: JAMA Network Open 2020. DOI: 10.1001/jamanetworkopen.2020.10411
DERMATOLOGY PRACTICE 2020; 30(5): 33
