Performance of WOUNDCHEK Bacterial Status

Launched by WOUNDCHEK LABORATORIES BV · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the WOUNDCHEK™ Bacterial Status (WCBS) test, which helps doctors understand whether a wound is infected or not and guides treatment decisions. The researchers want to see how well this test performs when assessing wounds, particularly in patients who have specific types of wounds that are not showing clear signs of infection.

To participate in this study, you need to be at least 18 years old and have a certain type of wound, like a venous leg ulcer, diabetic foot ulcer, or pressure ulcer, that has been present for at least 21 days but less than 6 months. It’s important that your wound shows no more than two signs of infection, as determined by the study team. Participants will be asked to agree to follow all study requirements and provide consent. If you join the study, you'll help researchers learn more about how to treat wounds effectively, but please note that if your wound heals and then reopens, you won’t be able to participate again.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject has presented to the participating study site with a VLU, DFU and / or a PU that is suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show more than two of the NERDS signs of infection.
• • 2. Subject is 18 years of age or older.
• • 3. The wound is between 21 days and 6 months of age or more than 6 months of age if less than 1cm2 in area.
• • 4. Subject agrees to complete all aspects of the study and provides written Informed Consent per IRB requirements.
• Exclusion Criteria:
• • 1. Subject does not meet inclusion criteria.
• • 2. Target wound contains a malignancy.
• • 3. Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
• • 4. Subject is confirmed to be positive for HIV or hepatitis
• • .
• • 5. Subject is unable or unwilling to provide informed consent.
• • 6. A designated wound area may only be enrolled once in the study. For example, if an enrolled wound heals to complete closure and then re-opens, it cannot be re-enrolled in this study.