RecruitingNCT06501105

Performance of WOUNDCHEK Bacterial Status

Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status

Sponsor

Woundchek Laboratories BV

Enrollment

75 participants

Start Date

Jun 18, 2024

Study Type

OBSERVATIONAL

Conditions

Wound Heal

Summary

The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) when the test result is used to inform treatment decisions.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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.
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.