Performance of WOUNDCHEK Bacterial Status

Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Device: WOUNDCHEK Bacterial Status

Detailed Description

The clinician treating the wound will be allowed to use the test result in treatment decisions. The pretest treatment plan will be documented on the Case Report Form (CRF) prior to performing the WCBS test. After receiving the test result the clinician will document the post-test treatment plan. The healing outcome at 12 weeks following the test will be recorded on the CRF. The study will evaluate the healing outcomes compared to when test results are not used to assist in treatment decisions with study success defined as a higher healing rate and/or mean wound size reduction for WCBS positive wounds than obtained in the study PROT-2023-001. Also, the healing rate of wounds with a negative test result will be compared to the pretest rate to ensure that clinicians do not neglect and under treat this cohort with success criteria being that the WCBS negative wound healing rate is not worse than the pre-test healing rate. Additionally, the study will establish whether there are any device related Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs).

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Jack Wilkens, MBA; Phone Number: 305 926 8380; Email: jack.wilkens@woundchek.com
• Study Contact Backup: Name: Simon W Bayliff, BS; Phone Number: +44 7917 650027; Email: simon.bayliff@woundchek.com

Study Locations

• United States
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Health Comprehensive Wound Healing & Hyperbaric Center
      • Contact: Alisha Oropallo, MD; Phone Number: 516-233-3780; Email: aoropallo@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

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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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.
WOUNDCHEK Bacterial Status negative; Wounds negative for bacterial protease activity. Pre- and post-test treatment plan recorded.	Device: WOUNDCHEK Bacterial Status; Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOUNDCHEK Bacterial Status negative wound healing rate	The pre-test non-healing rate (i.e., [Non-Healed wounds/Total wounds]*100) minus the WCBS Negative wound non-healing rate (i.e. [Non-healed wounds with a negative WCBS result/Total wounds]*100) will be less than or equal to zero.	12 weeks
Adverse events	There will be no device related serious adverse events (SAE) or unanticipated adverse device effects (UADE).	12 weeks

Collaborators and Investigators

• Sponsor: Woundchek Laboratories BV
• Collaborators: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PROT-2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No