Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
ConditionVenous Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCutoSense Oy
About this trial
The purpose of this study is to investigate the functionality of a new type of wound monitoring method and measurement system for monitoring healing of venous ulcers. The system is consisted of a wound dressing with electrodes (eDressing), a bioimpedance measurement device and a mobile phone application.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 is not wider than 5 cm and the electrode dressing can be placed on the wound as intended. The wound should be located above the ankle, on the skin area where the electrode dressing can be placed properly.
Disqualifiers
Clinical wound infection at the time of the study
The subject has an intravenous (in Tampere: A venous operation) procedure within 2 months
Significant arterial circulatory disorder or adherence problem that prevents compression therapy (in Tampere: Contraindication for compression therapy, e.g. significant arterial circulatory disorder or severe heart failure)
Subject movement 2-3 times a week during the study to the study site is difficult to arrange (in Tampere: Subject not able to commit to study visits 2-3 times a week.)
Trial design
Design model
Single group
Treatments tested in this trial
WoundWatch® wound monitoring system
DeviceeDressing will be applied along with the compression therapy and the standard absorbing dressings. The subjects will be monitored using the WoundWatch® system. The subjects will have 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Study subject with venous ulcerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Wound Status Index (WSI) vs. wound surface area
Correlation analysis between the WSI and the wound surface area.
Time frame
From admission to discharge, up to 8 weeks.2
Wound Status Index (WSI) vs. wound surface area
Bland-Altman (agreement) analysis between the WSI and the wound surface area.
Time frame
From admission to discharge, up to 8 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CutoSense Oy
Lead sponsor
University Clinical Centre, Gdansk
Collaborator
Medical University of Gdansk
Collaborator
Tampere University Hospital
Collaborator
Source ClinicalTrials.gov