Performance of WOUNDCHEK Bacterial Status

Eligibility 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.
• 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.