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

Launched by CUTOSENSE OY · Mar 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to monitor the healing of venous ulcers, which are sores that can develop on the legs due to poor blood flow. The study is testing a special dressing that has electrodes, along with a device that measures how well the wound is healing and a mobile app for tracking progress. This method aims to help healthcare providers better understand how these wounds heal over time.

To participate in the study, you must be at least 18 years old and have a chronic ulcer caused by venous insufficiency, which means your veins are not working properly to return blood to your heart. The wound should be small (no larger than 5 x 5 cm), located above the ankle, and expected to heal within two months. If you are interested in joining, you’ll need to be able to attend the study site 2-3 times a week and follow the instructions from the medical team. If you have a current infection in the wound or certain health issues that affect blood flow, you may not be eligible. Overall, this study hopes to provide valuable insights into treating venous ulcers more effectively.

Gender

ALL

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.