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

RecruitingNAAges 18 Years - anyAllCutoSense Oy
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 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 Exclusion Criteria: * 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 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.
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What it tests

  • WoundWatch® wound monitoring system
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Where

2 sites
TAYS Haavakeskuksen poliklinikka
Tampere, Finland
University Clinical Centre, Gdańsk
Gdansk, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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