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

Venous Ulcer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The technical principle of the monitoring method is based on the quasimonopolar bioimpedance measurement. The measurement system consists of a bioimpedance measuring device, a wound dressing with electrodes (eDressing) and a mobile application for use with a mobile phone. The electrode dressing is placed on top of a wound, in contact with the wound tissue. The other necessary dressing layers (such as absorbent dressings and compression bandages) are placed over the electrode dressing. The aim is to keep the electrode bandage on the wound for seven consecutive days. Other dressings can be changed when necessary. However, the electrode dressing can be removed and replaced whenever due to medical necessity. During a study subject visit, the bioimpedance measurement is made, the uppermost dressings are opened carefully and it is ensured that the wound condition is as expected. Upon the replacement of the electrode dressing, the wound is photographed and documented. The wound area is measured, and the findings are recorded. A maximum of 20 subjects (10 to 20 subjects) with venous ulcers will be recruited for the study. Adults with venous ulcer who are applicable for compression therapy treatment and whose wound(s) fit on the area of no larger than 5 x 5 cm and whose wounds are do excrete excessively can be recruited to the study. Previous surgical venous procedure is not an exclusion criteria for enrollment, but surgical procedure can not be performed during the study. A subject shall visit the clinic 2-3 times a week, according to the doctor's or study nurse's assessment. Wound healing is monitored until the wound re-epithelized (>90% of initial wound surface area) or maximum two months. Thus, there will be a maximum of 24 study visits per subject. ;

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

• NCT number: NCT05805137
• Study type: Interventional
• Source: CutoSense Oy
• Contact: Atte Kekonen, M.Sc.
• Phone: +358407273627
• Email: atte.kekonen@cutosense.fi
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Completion date: December 31, 2023