Burn Wound, Diabetic Foot Ulcer, Infected Surgical Wound, Pressure Ulcer, Skin Flap, Skin Graft, Venous Leg Ulcer
Conditions
Brief summary
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.
Interventions
DEVICEPLASOMA
Treatment with cold plasma device
Sponsors
Diabetes Fonds
Pathology and Medical Microbiology
Plasmacure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited to: * diabetic ulcers (Wagner-Meggitt classification system/ University of Texas classification system: grades 1-3) * venous ulcers * pressure ulcers (international NPUAP/EPUAP classification system: categories/stages II-IV) * burn wounds (second and third degree) * skin grafts and flaps * infected post-surgical ulcers. Standard wound care has not resulted in sufficient healing after at least two weeks (including first line care) (Ref 25, Ref 26). Note: There is no upper limit for the duration that the wound exists. In case a subject has multiple wounds that meet the in- and
Exclusion criteria
, the wound with the longest duration will be chosen for the study. INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 4.5 cm (\ 16 cm2 wound surface area for circular wounds). INCL3: have a minimum age of 18 years old. INCL4: for home care treatments only: have a grounded wall socket available for connection of PLASOMA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety PLASOMA - device related SAEs | 12 months | device related SAEs |
| Efficacy PLASOMA - bacterial load reduction - Staphylococcus aureus | once at week 1 (wound swab directly before and after first PLASOMA treatment) | Reduction in number of S. aureus colonies, using wound swab and quantitative analysis |
| Efficacy PLASOMA - wound surface area reduction | 12 weeks | Wound surface area reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy PLASOMA- wound healing | 12 weeks | Wound healing - wound surface area reduction - wound volume reduction - time to healing |
| Efficacy PLASOMA - Quality of Life | 14 weeks | Quality of Life, using RAND-36 questionnaire |
| Efficacy PLASOMA - Ulcer recurrence | 12 months | Ulcer recurrence |
| Safety PLASOMA - all AEs | 12 months | Safety reporting |
| Efficacy PLASOMA - wound pain | 12 weeks | wound pain (0-10 numerical rating scale) |
| Health Technology Assessment PLASOMA | 12 weeks | resource usage PLASOMA |
| Patient acceptability | 12 weeks | Patient acceptability (subjects will be asked if they are happy with the PLASOMA treatment) |
| Efficacy PLASOMA - wound infection | 12 weeks | wound infection (clinical classification) |
| Safety PLASOMA - wound appearance | 24 weeks | wound appearance |
| Efficacy PLASOMA - Bacterial load reduction | once at week 1 (wound swab directly before and after first PLASOMA treatment) | Bacterial load reduction (total load and Pseudomonas aeruginosa), using wound swab and semi-quantitative analysis |
Countries
Netherlands
Outcome results
None listed