Multi-arm, phase three clinical trial
A multi-center three-arm phase 3 clinical study is running that will include in total hundreds of patients suffering from non-healing wounds. One study arm will receive standard care with wound dressings, a second and third arm will receive standard care in combination with PLASOMA treatment once and twice per week.
All preparatory activities are completed. The clinical research associates and application specialists are recruited, the study protocol has been finalized and approved by the METC- and national authorities, and all PLASOMA systems to execute the trial are in place, including a digital app to assess the wound characteristics. The study is published at www.clinicaltrials.gov. The sites have been trained on the use of PLASOMA, on how to include patients and on how to collect the data correctly. Despite delays and set-backs due to covid-19 the study is running well and inclusion rates are ramping up. It’s too early though to tap results from this study yet.
PLASOMA suitable for treatment of large wounds and for home use
The next generation PLASOMA system is under development to make it applicable for use at home and for a wider range of wound sizes and shapes. Plasmacure solved various technical challenges along the road. Larger cold plasma pads are prepared and prototyped. The cold plasma pulser is adapted for that, as well for the use case at home.
Dissemination and communication
Multiple channels are used to disseminate and communicate our story and results. Via the website, via publications in wound care magazines and via the social media, various press releases, blogs, case studies, whitepapers and articles for non-specialists and specialists are published. Recently, a scientific publication about the first clinical results was published in the leading Journal of Wound Care.
Through online and real-life conferences Plasmacure reaches out to the leading key opinion leaders in Europe. National patient organizations and insurance companies are contacted and willing to support PLASOMA.
Various videos have been made to explain the wound healing and treatments for chronic wounds with plasma treatment to patients and professionals. Also, the impact of chronic wounds on the quality of life and promising results of PLASOMA are discussed. Plasmacure was featured prime time on Dutch national television for the general public, resulting in a high response from patients and professionals.
