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

NCT05805137 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-17

No results posted yet for this 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.

Conditions

  • Venous Ulcer

Interventions

DEVICE

WoundWatch® 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.

Sponsors & Collaborators

  • University Clinical Centre, Gdansk

    collaborator OTHER

  • Medical University of Gdansk

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • CutoSense Oy

    lead INDUSTRY

Principal Investigators

  • Piotr Spychalski, MD, Ph.D. · Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Finland
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05805137 on ClinicalTrials.gov