Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System (WoundWatch™)
Venous Ulcer
About this trial
This is an interventional other trial for Venous Ulcer focused on measuring Venous ulcer, Monitoring, Bioimpedance, Electrode array, Wound dressing
Eligibility Criteria
Inclusion Criteria: Age at least 18 years The subject has a chronic lower extremity ulcer with a primary etiology of venous insufficiency. The previous venous procedure is not an obstacle to the study Compression therapy can be implemented The wound has a maximum surface area of 5 x 5 cm and can fit in an area of 5 cm x 5 cm. The wound should be located above the ankle, on the skin area where the electrode dressing can be placed properly. The wound is not deep with steep edges or cavity-like The wound is not highly excreting The wound can be expected to heal within two months (area reduced ≥ 90% from baseline) The subject gives consent to the study and commits to following the instructions of the medical staff Exclusion Criteria: Clinical wound infection at the time of the study The subject has an intravenous procedure within 2 months Significant arterial circulatory disorder or adherence problem that prevents compression therapy Subject movement 2-3 times a week during the study to the study site is difficult to arrange Diagnosed epoxy resin allergy Any other reasons of potential study subject non-compliance by the opinion of the investigator
Sites / Locations
- University Clinical Centre, GdańskRecruiting
Arms of the Study
Arm 1
Experimental
Study subject with venous ulcer
The subjects will be monitored using the WoundWatch wound management system two to three study visits per week until the venous ulcer has healed (surface area has decreased at least 90%) or up to two months.