Monitoring venous ulcers with a new bioimpedance method
Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
This study is testing a new way to monitor the healing of venous ulcers using a special dressing and a mobile app to see if it helps track progress better for adults with these wounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CutoSense Oy Industry-sponsored |
| Locations | 2 sites (Tampere and 1 other locations) |
| Trial ID | NCT05805137 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic venous ulcers that are not wider than 5 cm and suitable for compression therapy.
Not a fit: Patients with active clinical wound infections or significant arterial circulatory disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a more effective way to monitor and promote healing in patients with venous ulcers.
How similar studies have performed: While similar approaches have been explored, this specific bioimpedance method for monitoring venous ulcers is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Tampere and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.