Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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