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RecruitingNCT05805137WoundWatch®Updated Mar 17, 2026

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

An interventional study of WoundWatch® wound monitoring system in Venous Ulcer, sponsored by CutoSense Oy. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by CutoSense Oy · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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 electrode dressing is kept on the wound for maximum of seven consecutive days. The electrode dressing can be removed and replaced when needed due to medical reasons. Other dressings can be changed considered necessary.

During a study subject visit, the bioimpedance measurement is made using the device, 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 with venous ulcers will be recruited for the study in two study sites (Gdansk, Poland and Tampere, Finland).

Adult subjects (≥18 years) with venous ulcer who are applicable for compression therapy treatment, whose ulcer is not wider than 5 cm and does not excrete excessively can be recruited to the study. Previous surgical venous procedure is not an exclusion criterion 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.

In addition to scientific objectives, the results of this study are also used as part of clinical evidence when submitting the technical documentation to Notified Body for assessment of the conformity of the device before being placed on the market.

02

Conditions studied

  • Venous Ulcer

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Keywords

  • Venous ulcer
  • Monitoring
  • Bioimpedance
  • Electrode array
  • Wound dressing
03

In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's planned enrollment of 20 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

This is the only study on the registry with CutoSense Oy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age at least 18 years
  • The subject has a chronic lower extremity ulcer with a primary etiology of venous insufficiency. The previous venous procedure is not an obstacle to the study
  • Compression therapy can be implemented
  • The wound is not wider than 5 cm and the electrode dressing can be placed on the wound as intended. The wound should be located above the ankle, on the skin area where the electrode dressing can be placed properly.
  • The wound is not deep with steep edges or cavity-like
  • The wound is not highly excreting
  • The wound can be expected to heal within two months (area reduced ≥ 90% from baseline)
  • The subject gives consent to the study and commits to following the instructions of the medical staff

Exclusion criteria

Exclusion Criteria:

  • Clinical wound infection at the time of the study
  • The subject has an intravenous (in Tampere: A venous operation) procedure within 2 months
  • Significant arterial circulatory disorder or adherence problem that prevents compression therapy (in Tampere: Contraindication for compression therapy, e.g. significant arterial circulatory disorder or severe heart failure)
  • Subject movement 2-3 times a week during the study to the study site is difficult to arrange (in Tampere: Subject not able to commit to study visits 2-3 times a week.)
  • Diagnosed epoxy resin allergy
  • Any other reasons of potential study subject non-compliance by the opinion of the investigator

Additional local exclusion criteria in Tampere site:

  • Special groups, such as pregnant women/patients trying to conceive during the study or patients with reduced autonomy
  • Subject with any implantable electrical device. Such as pacemaker or implanted defibrillator. Patient has other electrically conductive implanted material in legs. Such as a metallic prostheses.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Study subject with venous ulcer

    The subjects will be monitored using the WoundWatch wound management system 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.

    Device: WoundWatch® wound monitoring system

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.

    Also known as: Bioimpedance measurement of wound healing

06

What researchers measure

Primary outcomes

  1. Wound Status Index (WSI) vs. wound surface area

    Correlation analysis between the WSI and the wound surface area.

    Time frame: From admission to discharge, up to 8 weeks.

  2. Wound Status Index (WSI) vs. wound surface area

    Bland-Altman (agreement) analysis between the WSI and the wound surface area.

    Time frame: From admission to discharge, up to 8 weeks.

07

Study locations

2 of 2 sites recruiting
  • TAYS Haavakeskuksen poliklinikka
    Tampere, 33520, Finland
    • Tiina Ahti, MD, Ph.D. · Contact · tiina.ahti@pirha.fi · +358 45 7396 5952
    • Atte Kekonen, M.Sc. · Contact · atte.kekonen@cutosense.fi · +40 727 3627
    • Tiina Ahti, MD, Ph.D. · Principal investigator
    • Teea Salmi, MD, Ph.D. · Sub investigator
    Recruiting
  • University Clinical Centre, Gdańsk
    Gdansk, Poland
    Recruiting
08

References and documents

Publications

  • Kekonen A, Bergelin M, Eriksson JE, Vaalasti A, Ylanen H, Kielosto S, Viik J. Bioimpedance method for monitoring venous ulcers: Clinical proof-of-concept study. Biosens Bioelectron. 2021 Apr 15;178:112974. doi: 10.1016/j.bios.2021.112974. Epub 2021 Jan 7. PubMed 33524705 ↗
  • Kekonen A, Bergelin M, Johansson M, Kumar Joon N, Bobacka J, Viik J. 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. Sensors (Basel). 2019 May 31;19(11):2505. doi: 10.3390/s19112505. PubMed 31159298 ↗
  • Kekonen A, Bergelin M, Eriksson JE, Vaalasti A, Ylanen H, Viik J. Bioimpedance measurement based evaluation of wound healing. Physiol Meas. 2017 Jun 22;38(7):1373-1383. doi: 10.1088/1361-6579/aa63d6. PubMed 28248191 ↗
  • Antoszewska M, Spychalski P, Kekonen A, Viik J, Baranska-Rybak W. Bioimpedance sensor array for monitoring chronic wounds: Validation of method feasibility. Int Wound J. 2024 Aug;21(8):e14899. doi: 10.1111/iwj.14899. PubMed 39099180 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05805137
Lead sponsor
CutoSense Oy
Collaborators
University Clinical Centre, Gdansk, Medical University of Gdansk, Tampere University Hospital
Responsible party
Sponsor
First posted
Apr 7, 2023
Start date
Apr 20, 2023
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 17, 2026

Study contacts

Atte Kekonen, M.Sc.
Contact
atte.kekonen@cutosense.fi
+358407273627
Tuomas Lunden, B.Sc.
Contact
tuomas.lunden@cutosense.fi
+358407211679
Piotr Spychalski, MD, Ph.D.
principal investigator · Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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