NCT05805137 Monitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System
| NCT ID | NCT05805137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CutoSense Oy |
| Condition | Venous Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-04-20 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-04-20 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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.
Contact & Investigator
Piotr Spychalski, MD, Ph.D.
PRINCIPAL INVESTIGATOR
Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk
Frequently Asked Questions
Who can join the NCT05805137 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05805137 currently recruiting?
Yes, NCT05805137 is actively recruiting participants. Contact the research team at atte.kekonen@cutosense.fi for enrollment information.
Where is the NCT05805137 trial being conducted?
This trial is being conducted at Tampere, Finland, Gdansk, Poland.
Who is sponsoring the NCT05805137 clinical trial?
NCT05805137 is sponsored by CutoSense Oy. The principal investigator is Piotr Spychalski, MD, Ph.D. at Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk. The trial plans to enroll 20 participants.