NCT06501105 · Woundchek Laboratories BV
Performance of WOUNDCHEK Bacterial Status
What this study is about
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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Subject does not meet inclusion criteria.
- 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.
Where
- Lake Success, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2024 · Source of record for eligibility and locations