Recruiting

WOUNDCHEK™ Bacterial Status

Sponsor:

Woundchek Laboratories BV

Code:

NCT06501105

Conditions

Wound Heal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

WOUNDCHEK Bacterial Status

Study Details

Brief summary:

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.

Conditions

Wound Heal

Study ID

NCT06501105

Start date

Jun 18, 2024

Status verified date

Jul, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

WOUNDCHEK Bacterial Status positive

Wounds positive for bacterial protease activity that may delay healing if untreated. Pre- and post-test treatment plan recorded.

WOUNDCHEK Bacterial Status negative

Wounds negative for bacterial protease activity. Pre- and post-test treatment plan recorded.

Interventions

WOUNDCHEK Bacterial Status

Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.

Primary outcome measure

  • Healing rate and mean percent wound area reduction [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Northwell Health Comprehensive Wound Healing & Hyperbaric Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

More Information

Sponsor

Woundchek Laboratories BV

Last update posted

Jul 15, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Woundchek Laboratories BV on 2024-07-15.