WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users

Description

The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) with untrained users in diverse CLIA waived locations and trained users and compare the results to those obtained in the study used for De Novo approval (DEN180014). Untrained and trained users are as defined in the FDA guidance document entitled 'Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices' (Feb 2020). The test result will be blinded to the clinician treating the wound. The healing outcome at 12 weeks following the test will be compared for wounds positive vs negative for bacterial protease activity (BPA). Study success criteria will be that the positive likelihood ratio (PLR) of a BPA positive wound being non-healing at 12 weeks for both trained and untrained users will be statistically comparable to the PLR obtained in the study submitted for DEN180014.

Conditions

Wound

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Study Overview

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Study Details

Study overview

The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) with untrained users in diverse CLIA waived locations and trained users and compare the results to those obtained in the study used for De Novo approval (DEN180014). Untrained and trained users are as defined in the FDA guidance document entitled 'Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices' (Feb 2020). The test result will be blinded to the clinician treating the wound. The healing outcome at 12 weeks following the test will be compared for wounds positive vs negative for bacterial protease activity (BPA). Study success criteria will be that the positive likelihood ratio (PLR) of a BPA positive wound being non-healing at 12 weeks for both trained and untrained users will be statistically comparable to the PLR obtained in the study submitted for DEN180014.

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

WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users

Condition
Wound
Intervention / Treatment

-

Contacts and Locations

Salem

Salem VA Medical Centre, Salem, Virginia, United States, 24153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Woundchek Laboratories BV,

Aliza Lee, DPM, PRINCIPAL_INVESTIGATOR, Salem VA

Study Record Dates

2025-01-31