Performance of WOUNDCHEK Bacterial Status

NCT06501105 | Recruiting FDA Device

• 1 other identifier: PROT-2023-002
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Healing rate and mean percent wound area reduction

  Rate of healing and/or mean percent wound area reduction for WOUNDCHEK Bacterial Status positive wounds will be higher than obtained in the clinical study PROT-2023-001

  12 weeks

Secondary Outcomes (2)

• WOUNDCHEK Bacterial Status negative wound healing rate

  12 weeks

• Adverse events

  12 weeks

Study Arms (2)

WOUNDCHEK Bacterial Status positive

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

Device: WOUNDCHEK Bacterial Status

WOUNDCHEK Bacterial Status negative

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

Device: WOUNDCHEK Bacterial Status

Interventions

WOUNDCHEK Bacterial Status DEVICE

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

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: Non-Probability Sample

Study Population

Patients attending the wound clinic with a venous leg ulcer, diabetic foot ulcer or pressure ulcer not considered to be infected and meeting the inclusion criteria.

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:

• 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
• Northwell Health: collaborator

Study Sites (1)

Northwell Health Comprehensive Wound Healing & Hyperbaric Center

Lake Success, New York, 11042, United States

RECRUITING

Central Study Contacts

Jack Wilkens, MBA

CONTACT

305 926 8380; jack.wilkens@woundchek.com

Simon W Bayliff, BS

CONTACT

+44 7917 650027; simon.bayliff@woundchek.com

Study Design

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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: June 18, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)