Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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

Locations
Other Locations
Finland
TAYS Haavakeskuksen poliklinikka
RECRUITING
Tampere
Poland
University Clinical Centre, Gdańsk
RECRUITING
Gdansk
Contact Information
Primary
Atte Kekonen, M.Sc.
atte.kekonen@cutosense.fi
+358407273627
Backup
Tuomas Lunden, B.Sc.
tuomas.lunden@cutosense.fi
+358407211679
Time Frame
Start Date: 2023-04-20
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: CutoSense Oy
Collaborators: Tampere University Hospital, Medical University of Gdansk, University Clinical Centre, Gdansk

This content was sourced from clinicaltrials.gov