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New treatment option for Venous Ulcer
Official title Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
ClinicalTrials.gov ID: NCT05805137
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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 wound is not deep with steep edges or cavity-like
You likely can't join 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...
- 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...
- 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:
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tampere, Finland
- Gdansk, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampere, Finland; Gdansk, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.