Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms