Status:
COMPLETED
WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users
Lead Sponsor:
Woundchek Laboratories BV
Conditions:
Wound
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) with untrained users in diverse CLIA waived locations and trained users and compare the results ...
Detailed Description
WCBS is an in vitro diagnostic chromatographic test for the qualitative detection of bacterial protease activity directly from wound fluid samples collected with a swab. The WCBS test is intended for ...
Eligibility Criteria
Inclusion
- 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.
- Subject is 18 years of age or older.
- The wound is between 21 days and 6 months of age or more than 6 months of age if less than 1cm2 in area.
- Subject agrees to complete all aspects of the study and provides written Informed Consent per IRB requirements.
Exclusion
- Subject does not meet inclusion criteria.
- The wound is less than 21 days of age or more than six months if larger than 1cm2 in area.
- Topical antimicrobial treatment will be started on the target wound at the time of subject enrollment. Note: Specific treatment used will be left to the PI's discretion.
- Topical antimicrobial treatment is being used on the target wound at the time of subject enrollment, and the treatment will be continued. Note: Specific treatment used will be left to the PI's discretion.
- Target wound contains a malignancy.
- Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
- Subject is confirmed to be positive for HIV or hepatitis.
- Subject is unable or unwilling to provide informed consent.
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 14 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06560125
Start Date
August 1 2024
End Date
February 14 2025
Last Update
July 17 2025
Active Locations (1)
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1
Salem VA Medical Centre
Salem, Virginia, United States, 24153