The world’s first placebo controlled clinical trial confirms the successful application of the kINPen® MED plasma jet in the treatment of diabetic foot ulcera:
July, 22nd 2020
The Study
Population
65 diabetic foot wounds
- Adult patients with diabetic foot syndrome
- Wagner-Armstrong Classification grade 1 B and 2 B
- Average age: 68.5 years (standard deviation 9.1 years)
Study centres
Two German hospitals:
- HDZ NRW, University Hospital for the treatment of cardiac, vascular and diabetic diseases of the Ruhr University of Bochum, Bad Oeynhausen, Germany
- Medical centre for cardiac and diabetic diseases, Karlsburg, Germany)
Methodology
62 wounds were randomised
- 31 wounds treated with standard wound therapy plus cold atmospheric plasma (CAP): 8 CAP applications (30s/cm² wound surface) within 14 days
- 31 wounds treated with standard wound therapy plus placebo control: 8 applications of placebo (simulated plasma) within 14 days
Primary study endpoints
Reduction of wound surface, the infection status of the wound and microbial load compared to the start of the therapy
Findings
Reduction of wound surface
After 8 treatments, the CAP therapy achieved the following results when compared to the placebo (measured at visit No. 9):
- Significant increase of wound healing
- Reduction of overall wound surface
- Faster relevant reduction of wound surface
Effect of cold plasma on activation of wound healing
- CAP superior to placebo with regard to infection status and microbial load reduction
- The results confirm that atmospheric cold plasma has its own inherent activating effect on wound healing
Potential shorter hospitalisation of DFS patients