Monitoring venous ulcers with a new bioimpedance method

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates a novel wound monitoring method using a bioimpedance measurement system to track the healing of venous ulcers. The system includes a specialized wound dressing with electrodes, a bioimpedance measuring device, and a mobile application for data collection. The electrode dressing is applied directly to the wound and can be replaced as needed, while measurements are taken to assess healing progress. The study aims to recruit up to 20 adult participants with specific criteria related to their venous ulcers across two locations in Poland and Finland.

Why it matters

Who can join: the full rules

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.

Where it's running

• TAYS Haavakeskuksen poliklinikka
  Tampere, Finland Recruiting
• University Clinical Centre, Gdańsk
  Gdansk, Poland Recruiting

Study contacts

• Principal investigator: Piotr Spychalski, MD, Ph.D. — Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
• Study coordinator: Atte Kekonen, M.Sc.
• Email: atte.kekonen@cutosense.fi
• Phone: +358407273627

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.