Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm® VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622)

Authors


  • Conflicts of interest

    • D. Wandke serves as CEO of Cinogy GmbH, the sponsor of the study. All other authors declare no conflict of interest.
  • Funding sources

    • The study was funded by Cinogy GmbH and in part by the DFG (EM 63/8-1) and the Bundesministerium für Wirtschaft und Technologie (FKZ: 01FS12003) to SE.

Abstract

Background

Cold atmospheric plasma (CAP, i.e. ionized air) is an innovating promising tool in reducing bacteria.

Objective

We conducted the first clinical trial with the novel PlasmaDerm® VU-2010 device to assess safety and, as secondary endpoints, efficacy and applicability of 45 s/cm2 cold atmospheric plasma as add-on therapy against chronic venous leg ulcers.

Methods

From April 2011 to April 2012, 14 patients were randomized to receive standardized modern wound care (n = 7) or plasma in addition to standard care (n = 7) 3× per week for 8 weeks. The ulcer size was determined weekly (Visitrak®, photodocumentation). Bacterial load (bacterial swabs, contact agar plates) and pain during and between treatments (visual analogue scales) were assessed. Patients and doctors rated the applicability of plasma (questionnaires).

Results

The plasma treatment was safe with 2 SAEs and 77 AEs approximately equally distributed among both groups (P = 0.77 and P = 1.0, Fisher's exact test). Two AEs probably related to plasma. Plasma treatment resulted in a significant reduction in lesional bacterial load (P = 0.04, Wilcoxon signed-rank test). A more than 50% ulcer size reduction was noted in 5/7 and 4/7 patients in the standard and plasma groups, respectively, and a greater size reduction occurred in the plasma group (plasma −5.3 cm2, standard: −3.4 cm2) (non-significant, P = 0.42, log-rank test). The only ulcer that closed after 7 weeks received plasma. Patients in the plasma group quoted less pain compared to the control group. The plasma applicability was not rated inferior to standard wound care (P = 0.94, Wilcoxon–Mann–Whitney test). Physicians would recommend (P = 0.06, Wilcoxon–Mann–Whitney test) or repeat (P = 0.08, Wilcoxon–Mann–Whitney test) plasma treatment by trend.

Conclusion

Cold atmospheric plasma displays favourable antibacterial effects. We demonstrated that plasma treatment with the PlasmaDerm® VU-2010 device is safe and effective in patients with chronic venous leg ulcers. Thus, larger controlled trials and the development of devices with larger application surfaces are warranted.

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