Chronic wounds open wounds existing for more than 3 weeks
Conditions
Interventions
The intervention consists solely of adding the QWhet stimulator to the standard
wound treatment.
Sponsors
Q Care Medical Services B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with chronic wounds (at least 3 weeks old) - age older than 18 years - able to understand and willing to fill out questionaires
Exclusion criteria
Exclusion criteria: 1. pregnancy and lactation 2. Use of other internal electronic devices (e.g., pacemaker, internal defibrillator) 3. mental retardation 4. fever (above 38.5 degrees Celsius) 5. Active wound infection, to be assessed by the physician investigator on clinical grounds 6. under the age of 18 years 7. wounds with necrotic tissue 8. carcinoma or melanoma in the wound or adjacent skin 9. untreated osteomyelitis of the wound 10. allergy to aluminum 11. chronic wound located on the head, neck or on the thorax 12. participation in an investigational medicine or medical device study of which the primary end point has not been reached yet 13. any other condition which, at the discretion of the physician, may prevent successful completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with an ADE after 28 days of treatment with QWhet. H0: percentage of patients is larger than 5%. Ha: percentage of patients is less or equal to 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| The average percentage woundsurface area (length x width) reduction as compared to baseline after 28 days of treatment with QWhet. H0: average percentage woundsurface reduction less than 33% compared to baseline Ha: average percentage woundsurface reduction at least 33% compared to baseline | — |
Countries
Netherlands
Outcome results
None listed