NCT05805137

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

March 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

March 28, 2023

Last Update Submit

March 16, 2026

Conditions

Venous Ulcer

Keywords

Venous ulcerMonitoringBioimpedanceElectrode arrayWound dressing

Outcome Measures

Primary Outcomes (2)

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

    Correlation analysis between the WSI and the wound surface area.

    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.

    From admission to discharge, up to 8 weeks.

Study Arms (1)

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.

Device: WoundWatch® wound monitoring system

Interventions

WoundWatch® wound monitoring systemDEVICE

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
Study subject with venous ulcer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TAYS Haavakeskuksen poliklinikka

Tampere, 33520, Finland

RECRUITING

University Clinical Centre, Gdańsk

Gdansk, Poland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 33524705BACKGROUND

  • 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.

    PMID: 31159298BACKGROUND

  • 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.

    PMID: 28248191BACKGROUND

  • 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.

    PMID: 39099180BACKGROUND

Related Links

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Piotr Spychalski, MD, Ph.D.

    Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Atte Kekonen, M.Sc.

CONTACT

+358407273627atte.kekonen@cutosense.fi

Tuomas Lunden, B.Sc.

CONTACT

+358407211679tuomas.lunden@cutosense.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 7, 2023

Study Start

April 20, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)PL(1)