RecruitingNot ApplicableNCT05805137

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

Sponsor

CutoSense Oy

Enrollment

20 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

Venous Ulcer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable electrode patch device that uses bioimpedance measurements to track wound healing in people with chronic leg ulcers caused by poor vein function (venous insufficiency) — to see if this technology can predict healing outcomes more accurately. **You may be eligible if:** - You are 18 or older - You have a chronic leg ulcer caused primarily by venous insufficiency (poor vein blood flow) - Compression therapy can be used on your wound - Your wound is not wider than 5 cm and can accommodate the electrode patch - The wound is expected to heal significantly (at least 90% smaller) within two months - You are willing to attend study visits 2–3 times per week **You may NOT be eligible if:** - You have an active wound infection at the start of the study - You had a recent vein procedure in the leg (within 2 months) - You have a significant arterial circulation problem or severe heart failure that prevents compression therapy - You have a diagnosed allergy to epoxy resin - You cannot commit to the required follow-up visit schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWoundWatch® 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.