The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: 1. Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; 2. Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: * FU1: 2 weeks after end treatment period * FU2: 12 weeks after end treatment period * FU3: 12 months after start treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
101
Treatment with cold plasma device
Groene Hart Ziekenhuis
Gouda, Netherlands
Alrijne Ziekenhuis
Leiderdorp, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Expertisecentrum Wondzorg (EcW)
Oosterhout, Netherlands
Maxima Medisch Centrum (MMC)
Veldhoven, Netherlands
Safety PLASOMA - device related SAEs
device related SAEs
Time frame: 12 months
Efficacy PLASOMA - bacterial load reduction - Staphylococcus aureus
Reduction in number of S. aureus colonies, using wound swab and quantitative analysis
Time frame: once at week 1 (wound swab directly before and after first PLASOMA treatment)
Efficacy PLASOMA - wound surface area reduction
Wound surface area reduction
Time frame: 12 weeks
Safety PLASOMA - all AEs
Safety reporting
Time frame: 12 months
Safety PLASOMA - wound appearance
wound appearance
Time frame: 24 weeks
Efficacy PLASOMA - Bacterial load reduction
Bacterial load reduction (total load and Pseudomonas aeruginosa), using wound swab and semi-quantitative analysis
Time frame: once at week 1 (wound swab directly before and after first PLASOMA treatment)
Efficacy PLASOMA- wound healing
Wound healing - wound surface area reduction - wound volume reduction - time to healing
Time frame: 12 weeks
Efficacy PLASOMA - Quality of Life
Quality of Life, using RAND-36 questionnaire
Time frame: 14 weeks
Efficacy PLASOMA - Quality of Life
Quality of Life, using Wound-QoL questionnaire
Time frame: 14 weeks
Efficacy PLASOMA - Ulcer recurrence
Ulcer recurrence
Time frame: 12 months
Efficacy PLASOMA - wound infection
wound infection (clinical classification)
Time frame: 12 weeks
Efficacy PLASOMA - wound pain
wound pain (0-10 numerical rating scale)
Time frame: 12 weeks
Health Technology Assessment PLASOMA
resource usage PLASOMA
Time frame: 12 weeks
Patient acceptability
Patient acceptability (subjects will be asked if they are happy with the PLASOMA treatment)
Time frame: 12 weeks
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