Bioimpedance method for monitoring venous ulcers: Clinical proof-of-concept study.
Atte Kekonen, Mikael Bergelin, Jan-Erik Eriksson...
https://pubmed.ncbi.nlm.nih.gov/33524705Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05805137
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
4 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
Researchers are evaluating a new wound monitoring method and measurement system to track healing of venous ulcers. This system includes a special wound dressing with electrodes called eDressing, a bioimpedance measurement device, and a mobile phone application. The study aims to assess how well this technology tracks wound healing over time in adults with venous ulcers. The monitoring system works by placing the electrode dressing directly on the wound tissue, covered by other dressings as needed. The electrode dressing stays on for up to seven consecutive days and can be replaced for medical reasons. Participants receive compression therapy and are monitored using the WoundWatch system during 2 to 3 study visits per week until their ulcer has healed by at least 90% or up to two months, with a maximum of 24 visits. Participants will attend regular clinic visits where the wound is inspected, photographed, and measured. Bioimpedance measurements are taken with the device to evaluate wound status. The main measure is the Wound Status Index compared to wound surface area over up to 8 weeks. The study also supports device approval by providing clinical evidence. Participant involvement lasts until healing or two months, allowing detailed monitoring of venous ulcer recovery.
CONDITIONS
Brief Title
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age at least 18 years
- Chronic lower extremity ulcer caused by venous insufficiency
- Compression therapy can be implemented
- Wound no wider than 5 cm and located above the ankle where electrode dressing can be placed properly
- Wound is not deep, cavity-like, or with steep edges
- Wound is not highly excreting
- Wound expected to heal within two months (area reduced at least 90%)
- Consent given and commitment to follow medical staff instructions
You will not qualify if you...
- Clinical wound infection at the time of the study
- Venous or intravenous procedure within 2 months
- Significant arterial circulatory disorder or issues preventing compression therapy
- Difficulty attending 2-3 study visits per week
- Diagnosed allergy to epoxy resin
- Any other reason for potential non-compliance by investigator's opinion
- Pregnant women or patients trying to conceive during the study (Tampere site only)
- Patients with reduced autonomy (Tampere site only)
- Presence of any implantable electrical device or electrically conductive implants in legs (Tampere site only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 2 months or until the wound has healed (surface area reduced by at least 90%)
Participants receive the WoundWatch® wound monitoring system, including an electrode dressing placed on the wound along with compression therapy and standard absorbing dressings. The electrode dressing is replaced as needed, and wound condition is carefully monitored.
2 to 3 visits per week, up to 24 visits
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.
T
Tuomas Lunden, B.Sc.
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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Published Research Related To This Trial
Bioimpedance Sensor Array for Long-Term Monitoring of Wound Healing from Beneath the Primary Dressings and Controlled Formation of H2O2 Using Low-Intensity Direct Current.
Atte Kekonen, Mikael Bergelin, Max Johansson...
https://pubmed.ncbi.nlm.nih.gov/31159298Bioimpedance measurement based evaluation of wound healing.
Atte Kekonen, Mikael Bergelin, Jan-Erik Eriksson...
https://pubmed.ncbi.nlm.nih.gov/28248191Bioimpedance sensor array for monitoring chronic wounds: Validation of method feasibility.
Magdalena Antoszewska, Piotr Spychalski, Atte Kekonen...
https://pubmed.ncbi.nlm.nih.gov/39099180