Evaluating WOUNDCHEK Bacterial Status for wound healing decisions
Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status
This study is testing if the WOUNDCHEK Bacterial Status test can help doctors make better treatment decisions for patients with wounds to see if it leads to faster healing and smaller wounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Woundchek Laboratories BV Industry-sponsored |
| Locations | 1 site (Lake Success, New York) |
| Trial ID | NCT06501105 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the effectiveness of the WOUNDCHEK™ Bacterial Status (WCBS) test in guiding treatment decisions for patients with wounds. Clinicians will document their treatment plans before and after receiving the WCBS test results, allowing for a comparison of healing outcomes over a 12-week period. The study will evaluate whether using the WCBS test leads to improved healing rates and reduced wound sizes compared to standard treatment without the test. Additionally, it will monitor for any serious adverse events related to the device.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with venous leg ulcers, diabetic foot ulcers, or pressure ulcers suspected not to be infected.
Not a fit: Patients with infected wounds, malignancies, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance wound healing outcomes by providing clinicians with valuable information to tailor treatment plans.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving wound care outcomes through targeted treatment strategies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lake Success, New York
- Northwell Health Comprehensive Wound Healing & Hyperbaric Center — Lake Success, New York, United States (Recruiting)
Study contacts
- Study coordinator: Jack Wilkens, MBA
- Email: jack.wilkens@woundchek.com
- Phone: 305 926 8380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.