Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05805137

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

Led by CutoSense Oy · Updated on 2026-03-17

20

Participants Needed

2

Research Sites

193 weeks

Total Duration

On this page

Sponsors

C

CutoSense Oy

Lead Sponsor

U

University Clinical Centre, Gdansk

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 18 years
  • Chronic lower extremity ulcer caused by venous insufficiency
  • Suitable for compression therapy treatment
  • Wound not wider than 5 cm and located above the ankle where electrode dressing can be placed
  • Wound not deep with steep edges or cavity-like
  • Wound not highly excreting
  • Wound expected to heal within two months with at least 90% area reduction
  • Consent given and commitment to follow medical instructions
Not Eligible

You will not qualify if you...

  • Clinical wound infection at the time of the study
  • Intravenous or venous operation within 2 months before the study
  • Significant arterial circulation disorder or conditions preventing compression therapy
  • Difficulty attending study visits 2-3 times per week
  • Diagnosed allergy to epoxy resin
  • Any other reasons for potential non-compliance as judged by investigator
  • Pregnant women or those trying to conceive (Tampere site only)
  • Reduced autonomy (Tampere site only)
  • Presence of implantable electrical devices such as pacemakers, defibrillators, or metallic prostheses in legs (Tampere site only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

TAYS Haavakeskuksen poliklinikka

Tampere, Finland, 33520

Actively Recruiting

2

University Clinical Centre, Gdańsk

Gdansk, Poland

Actively Recruiting

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Research Team

A

Atte Kekonen, M.Sc.

CONTACT

T

Tuomas Lunden, B.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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