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Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System (WoundWatch™)

Primary Purpose

Venous Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
WoundWatch wound management system
Sponsored by
CutoSense Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Venous Ulcer focused on measuring Venous ulcer, Monitoring, Bioimpedance, Electrode array, Wound dressing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 has a maximum surface area of 5 x 5 cm and can fit in an area of 5 cm x 5 cm. 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: Clinical wound infection at the time of the study The subject has an intravenous procedure within 2 months Significant arterial circulatory disorder or adherence problem that prevents compression therapy Subject movement 2-3 times a week during the study to the study site is difficult to arrange Diagnosed epoxy resin allergy Any other reasons of potential study subject non-compliance by the opinion of the investigator

Sites / Locations

  • University Clinical Centre, GdańskRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study subject with venous ulcer

Arm Description

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.

Outcomes

Primary Outcome Measures

Wound Status Index (WSI) vs. wound surface area
Correlation analysis between the WSI and the wound surface area. The WSI is derived from the bioimpedance measurement results.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
April 20, 2023
Sponsor
CutoSense Oy
Collaborators
University Clinical Centre, Gdansk, Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT05805137
Brief Title
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
Acronym
WoundWatch™
Official Title
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CutoSense Oy
Collaborators
University Clinical Centre, Gdansk, Medical University of Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 aim is to keep the electrode bandage on the wound for seven consecutive days. Other dressings can be changed when necessary. However, the electrode dressing can be removed and replaced whenever due to medical necessity. During a study subject visit, the bioimpedance measurement is made, 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 (10 to 20 subjects) with venous ulcers will be recruited for the study. Adults with venous ulcer who are applicable for compression therapy treatment and whose wound(s) fit on the area of no larger than 5 x 5 cm and whose wounds are do excrete excessively can be recruited to the study. Previous surgical venous procedure is not an exclusion criteria 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer
Keywords
Venous ulcer, Monitoring, Bioimpedance, Electrode array, Wound dressing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study subject with venous ulcer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WoundWatch wound management system
Other Intervention Name(s)
Bioimpedance measurement of wound healing
Intervention Description
eDressing will be applied along with the compression therapy and the standard absorbing dressings. The subjects will be monitored using the WoundWatch wound management 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.
Primary Outcome Measure Information:
Title
Wound Status Index (WSI) vs. wound surface area
Description
Correlation analysis between the WSI and the wound surface area. The WSI is derived from the bioimpedance measurement results.
Time Frame
From admission to discharge, up to 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 has a maximum surface area of 5 x 5 cm and can fit in an area of 5 cm x 5 cm. 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: Clinical wound infection at the time of the study The subject has an intravenous procedure within 2 months Significant arterial circulatory disorder or adherence problem that prevents compression therapy Subject movement 2-3 times a week during the study to the study site is difficult to arrange Diagnosed epoxy resin allergy Any other reasons of potential study subject non-compliance by the opinion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atte Kekonen, M.Sc.
Phone
+358407273627
Email
atte.kekonen@cutosense.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Tuomas Lunden, B.Sc.
Phone
+358407211679
Email
tuomas.lunden@cutosense.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski, MD, Ph.D.
Organizational Affiliation
Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinical Centre, Gdańsk
City
Gdańsk
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Antoszewska, MD
Phone
+48698748705
Email
mmantoszewska@gmail.com
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski, MD, Ph.D.
Email
piotr.spychalski@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski, MD, Ph.D.
First Name & Middle Initial & Last Name & Degree
Magdalena Antoszewska, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33524705
Citation
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.
Results Reference
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PubMed Identifier
31159298
Citation
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.
Results Reference
background
PubMed Identifier
28248191
Citation
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.
Results Reference
background
Links:
URL
https://cutosense.fi/
Description
CutoSense Oy homepage (Sponsor)

Learn more about this trial

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

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