Diabetic ulcer pressure sores/decubitus
Conditions
Interventions
All subjects will receive (placebo) WMCS treatment thrice weekly for 45 minutes
per session during the maximum study related treatment of twelve weeks while
using the same dressings as received duri
Sponsors
Haaglanden Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age of 18 years and older - Mentally competent - Ankle-brachial index between 0.7-1.2 - In case of patients with diabetes: toe systolic pressure should be above 50mmHg - Signed the informed consent form - Hard-to-heal chronic wound as defined: Wounds existing over six weeks with a biological or physiological reason for stagnation of the healing process, such as diabetic ulcers, arterial or venous ulcers and pressure sores on the lower extremity with failure to achieve the expected wound healing progress with the use of standard outpatient wound care.
Exclusion criteria
Exclusion criteria: - Pregnancy - (Cardial) Implanted electrical device - (Skin)malignancy within the therapeutic range. - Epilepsy - Overshoot granulation tissue of the wound - Severe woundinfection - Any treatment with metal ion-containing wound care products - Ankle-brachial index 1.2 - In case of patients with diabetes: toe systolic pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main study parameter will be the monthly wound area reduction during the maximum study related treatment of twelve weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: days upon full epithelisation of the wound surface, pain reduction, complications compared to contemporary wound therapies, a monthly Patient Related Outcome Measure and a cost-effectiveness analysis from a healthcare perspective. | — |
Countries
Netherlands
Outcome results
None listed