Evaluating WOUNDCHEK Bacterial Status with Trained and Untrained Users

Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status With Trained vs Untrained Users

This study is testing how well the WOUNDCHEK Bacterial Status test works for detecting bacteria in wound samples when used by both trained and untrained people, to see if it affects healing outcomes after 12 weeks.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Woundchek Laboratories BV (Industry-sponsored)
• Locations: 1 site (Salem, Virginia)
• Trial ID: NCT06560125 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the performance of the WOUNDCHEK™ Bacterial Status (WCBS) test in detecting bacterial protease activity in wound fluid samples. It compares results from trained users to those from untrained users in various CLIA waived locations. The study will analyze healing outcomes at 12 weeks for wounds that are either positive or negative for bacterial activity, with the results being blinded to the treating clinician. The goal is to determine if the likelihood of non-healing is statistically comparable between both user groups and the previously established data.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic venous ulcers, diabetic foot ulcers, or pressure ulcers that are suspected not to be infected.

Not a fit: Patients with wounds that are either less than 21 days old or larger than 1cm² if older than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of wound assessments, leading to better management and healing outcomes for patients with chronic wounds.

How similar studies have performed: Other studies have shown success with similar diagnostic approaches, indicating potential for effective outcomes in this area.

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. The wound is less than 21 days of age or more than six months if larger than 1cm2 in area.
3. 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.
4. 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.
5. Target wound contains a malignancy.
6. Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
7. Subject is confirmed to be positive for HIV or hepatitis.
8. Subject is unable or unwilling to provide informed consent.
9. 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.

Where this trial is running

Salem, Virginia

• Salem VA Medical Centre — Salem, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Aliza Lee, DPM — Salem VA
• Study coordinator: Tracy Ochalek

Conditions Wound