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WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users

NCT06560125 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

OTHER

Standard care

Treatment appropriate for wound condition

Sponsors & Collaborators

  • Woundchek Laboratories BV

    lead INDUSTRY

Principal Investigators

  • Aliza Lee, DPM · Salem VA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2024-12-24
Completion
2025-02-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06560125 on ClinicalTrials.gov