Venous UlcerWoundWatch®NCT05805137
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
A study testing WoundWatch® wound monitoring system in people with Venous Ulcer, run by CutoSense Oy at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- WoundWatch® wound monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Finland1 site, 1 recruiting
- Recruiting
TAYS Haavakeskuksen poliklinikka
Tampere, 33520
Tiina Ahti, MD, Ph.D., +358 45 7396 5952, tiina.ahti@pirha.fi
Atte Kekonen, M.Sc., +40 727 3627, atte.kekonen@cutosense.fi
Poland1 site, 1 recruiting
- Recruiting
University Clinical Centre, Gdańsk
Gdansk
Magdalena Antoszewska, MD, +48698748705, mmantoszewska@gmail.com
Piotr Spychalski, MD, Ph.D., piotr.spychalski@gumed.edu.pl
About this study
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.
- Conditions
- Venous Ulcer
- Being tested
- WoundWatch® wound monitoring system
- Keywords
- Venous ulcer, Monitoring, Bioimpedance, Electrode array, Wound dressing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WoundWatch® wound monitoring systemDevice
Also called Bioimpedance measurement of wound healing
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.
| Study group | Role | What they receive |
|---|---|---|
| Study subject with venous ulcer | Experimental | 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. Receives: Device: WoundWatch® wound monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Status Index (WSI) vs. wound surface area
Correlation analysis between the WSI and the wound surface area.
Measured: From admission to discharge, up to 8 weeks.
Wound Status Index (WSI) vs. wound surface area
Bland-Altman (agreement) analysis between the WSI and the wound surface area.
Measured: From admission to discharge, up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start20 Apr 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CutoSense Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Clinical Centre, Gdansk, Medical University of Gdansk, Tampere University Hospital
- Responsible party
- Sponsor
- Investigators
- Piotr Spychalski, MD, Ph.D., Principal investigator, Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805137
- Sponsor's protocol ID
- WW001
- Other IDs
- R23094L (WW001 TAYS)
- Acronym
- WoundWatch®
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33524705Kekonen 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 31159298Kekonen 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 28248191Antoszewska 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
- ClinicalTrials.gov ID
- NCT05805137
- Acronym / sponsor ID
- WoundWatch® / WW001
- Conditions
- Venous Ulcer
- Keywords
- Venous ulcer, Monitoring, Bioimpedance, Electrode array, Wound dressing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CutoSense OyIndustry (pharma, biotech, devices)
- Collaborators
- University Clinical Centre, Gdansk, Medical University of Gdansk, Tampere University Hospital
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study subject with venous ulcer | Experimental | Device: WoundWatch® wound monitoring systemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WoundWatch® wound monitoring systemAlso: Bioimpedance measurement of wound healingeDressing 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. | Device | Study subject with venous ulcer |
Primary outcome
Wound Status Index (WSI) vs. wound surface area
Time frame: From admission to discharge, up to 8 weeks.
Correlation analysis between the WSI and the wound surface area.
Wound Status Index (WSI) vs. wound surface area
Time frame: From admission to discharge, up to 8 weeks.
Bland-Altman (agreement) analysis between the WSI and the wound surface area.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 33524705Kekonen 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.
- Background: PubMed 31159298Kekonen 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.
- Background: PubMed 28248191Kekonen 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.
- Background: PubMed 39099180Antoszewska 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.
- CutoSense Oy homepage (Sponsor)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piotr Spychalski, MD, Ph.D. principal investigator
Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WoundWatch® wound monitoring system in people with Venous Ulcer, run by CutoSense Oy at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atte Kekonen, M.Sc. (+358407273627, atte.kekonen@cutosense.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Status Index (WSI) vs. wound surface area (time frame: From admission to discharge, up to 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05805137, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.