Clinical trial NCT06501105: Performance of WOUNDCHEK Bacterial Status
Official title: Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wound Heal
Lead sponsor: Woundchek Laboratories BV
Sponsor class: INDUSTRY
Collaborators: name: Northwell Health
First posted: 2024-07-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Healing rate and mean percent wound area reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: WOUNDCHEK Bacterial Status negative wound healing rate
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Northwell Health Comprehensive Wound Healing & Hyperbaric Center
state: New York
Study officials:
References: