NCT05805137

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: CutoSense Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 electrode dressing is kept on the wound for maximum of seven consecutive days. The electrode dressing can be removed and replaced when needed due to medical reasons. Other dressings can be changed considered necessary. During a study subject visit, the bioimpedance measurement is made using the device, 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 with venous ulcers will be recruited for the study in two study sites (Gdansk, Poland and Tampere, Finland). Adult subjects (≥18 years) with venous ulcer who are applicable for compression therapy treatment, whose ulcer is not wider than 5 cm and does not excrete excessively can be recruited to the study. Previous surgical venous procedure is not an exclusion criterion 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. In addition to scientific objectives, the results of this study are also used as part of clinical evidence when submitting the technical documentation to Notified Body for assessment of the conformity of the device before being placed on the market.

Conditions

• Venous Ulcer

Interventions

Type	Name	Description
DEVICE	WoundWatch® wound monitoring system	eDressing 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.

Timeline

• Start date: 2023-04-20
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2023-04-07
• Last updated: 2026-03-17

Locations

2 sites across 2 countries: Finland, Poland