WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users

NCT06560125 | Completed FDA Device

• 1 other identifier: PROT-2023-001/004
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Complete wound closure

  12 weeks

Secondary Outcomes (1)

• Wound size reduction

  12 weeks

Study Arms (2)

WOUNDCHEK Bacterial Status positive

Wounds testing positive for bacterial protease activity

Other: Standard care

WOUNDCHEK Bacterial Status negative

Wounds testing negative for bacterial protease activity

Other: Standard care

Interventions

Standard care OTHER

Treatment appropriate for wound condition

WOUNDCHEK Bacterial Status negative; WOUNDCHEK Bacterial Status positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects attending wound clinic

You may qualify if:

• 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.

You may not qualify if:

• The wound is less than 21 days of age or more than six months if larger than 1cm2 in area.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Woundchek Laboratories BV: lead

Study Sites (1)

Salem VA Medical Centre

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Aliza Lee, DPM

  Salem VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 1, 2024
• Primary Completion: December 24, 2024
• Study Completion: February 14, 2025
• Last Updated: July 17, 2025

Record last verified: 2024-08

Locations

US (1)