WoundNCT06560125
WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users
An observational study of Wound, run by Woundchek Laboratories BV at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 14 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects attending wound clinic
Who may be able to join
- 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.
Who cannot join
- Subject does not meet inclusion criteria.
- The wound is less than 21 days of age or more than six months if larger than 1cm2 in area.
- Topical antimicrobial treatment will be started on the target wound at the time of subject enrollment. Note: Specific treatment used will be left to the PI's discretion.
- Topical antimicrobial treatment is being used on the target wound at the time of subject enrollment, and the treatment will be continued. Note: Specific treatment used will be left to the PI's discretion.
- Target wound contains a malignancy.
- Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status With Trained vs Untrained Users
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.
Read the detailed description
WCBS is an in vitro diagnostic chromatographic test for the qualitative detection of bacterial protease activity directly from wound fluid samples collected with a swab. The WCBS test is intended for use in adult patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patients are asymptomatic for clinical signs of infection. The test is intended for use with chronic wounds that are between 21 days and < 6 months of age and chronic wounds that are ≥ 6 months of age that are < 1cm2 in size. This test is indicated for use solely by health care professionals whose clinical practice primarily or routinely involves the assessment and treatment of chronic wounds. WCBS results are intended for use in conjunction with the assessment of other known risk factors for wound healing that significantly contribute to the risk for non-healing chronic wounds such as wound age, wound size, and vascular status.
This is a prospective study designed to evaluate the performance of WCBS by testing wound fluid swab samples collected from leg ulcers (LU), diabetic foot ulcers (DFU), and pressure ulcers (PU) in waived environments that represent the device's intended user locations by untrained users compared to trained users in environments certified to perform CLIA moderate complexity tests.
At the time of a Subject's initial study enrolment (Day 0), one wound fluid swab sample will be collected from the designated wound area of each Subject from whom informed consent has been obtained. All swab specimens will be collected using swabs provided with the test kit. For the purpose of this study, this swab will be tested at the time of collection on the WCBS test by clinical site staff members, according to product instructions.
All WCBS test operators will not be the treating clinician. Throughout the study, all health care providers responsible for treatment of the Subjects, will be blinded to the WCBS test results.
Over the course of the 12 weeks post Day 0, Subjects will be treated per each site's Standard of Care. For the purposes of this study, clinical healing status, determined by whether or not the wound has achieved complete closure over a 12-week time frame will be utilized as the primary "comparator method" for evaluation of device performance. A WCBS negative test result on a wound determined to be "healed" at or before the "Week 12" time point will be considered a "true negative". A WCBS positive test result on a wound determined to be "not healed" by the "Week 12" time point will be considered a "true positive". For wounds not healed by 12 weeks, the percent wound area reduction over the 12 week period will be calculated.
- Conditions
- Wound
- Being tested
- Standard care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Treatment appropriate for wound condition
| Study group | Role | What they receive |
|---|---|---|
| WOUNDCHEK Bacterial Status positive | Wounds testing positive for bacterial protease activity Receives: Other: Standard care | |
| WOUNDCHEK Bacterial Status negative | Wounds testing negative for bacterial protease activity Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Complete wound closure
Measured: 12 weeks
Secondary outcomes (1)
Wound size reduction
Percent change in wound size
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Aug 2024
- Primary completion24 Dec 2024
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woundchek Laboratories BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aliza Lee, DPM, Principal investigator, Salem VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560125
- Sponsor's protocol ID
- PROT-2023-001/004
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status With Trained vs Untrained Users
- ClinicalTrials.gov ID
- NCT06560125
- Acronym / sponsor ID
- PROT-2023-001/004
- Conditions
- Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Woundchek Laboratories BVIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
WCBS is an in vitro diagnostic chromatographic test for the qualitative detection of bacterial protease activity directly from wound fluid samples collected with a swab. The WCBS test is intended for use in adult patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patients are asymptomatic for clinical signs of infection. The test is intended for use with chronic wounds that are between 21 days and < 6 months of age and chronic wounds that are ≥ 6 months of age that are < 1cm2 in size. This test is indicated for use solely by health care professionals whose clinical practice primarily or routinely involves the assessment and treatment of chronic wounds. WCBS results are intended for use in conjunction with the assessment of other known risk factors for wound healing that significantly contribute to the risk for non-healing chronic wounds such as wound age, wound size, and vascular status.
This is a prospective study designed to evaluate the performance of WCBS by testing wound fluid swab samples collected from leg ulcers (LU), diabetic foot ulcers (DFU), and pressure ulcers (PU) in waived environments that represent the device's intended user locations by untrained users compared to trained users in environments certified to perform CLIA moderate complexity tests.
At the time of a Subject's initial study enrolment (Day 0), one wound fluid swab sample will be collected from the designated wound area of each Subject from whom informed consent has been obtained. All swab specimens will be collected using swabs provided with the test kit. For the purpose of this study, this swab will be tested at the time of collection on the WCBS test by clinical site staff members, according to product instructions.
All WCBS test operators will not be the treating clinician. Throughout the study, all health care providers responsible for treatment of the Subjects, will be blinded to the WCBS test results.
Over the course of the 12 weeks post Day 0, Subjects will be treated per each site's Standard of Care. For the purposes of this study, clinical healing status, determined by whether or not the wound has achieved complete closure over a 12-week time frame will be utilized as the primary "comparator method" for evaluation of device performance. A WCBS negative test result on a wound determined to be "healed" at or before the "Week 12" time point will be considered a "true negative". A WCBS positive test result on a wound determined to be "not healed" by the "Week 12" time point will be considered a "true positive". For wounds not healed by 12 weeks, the percent wound area reduction over the 12 week period will be calculated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WOUNDCHEK Bacterial Status positive | – | Other: Standard careWounds testing positive for bacterial protease activity |
| WOUNDCHEK Bacterial Status negative | – | Other: Standard careWounds testing negative for bacterial protease activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects attending wound clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Subject does not meet inclusion criteria.
- The wound is less than 21 days of age or more than six months if larger than 1cm2 in area.
- Topical antimicrobial treatment will be started on the target wound at the time of subject enrollment. Note: Specific treatment used will be left to the PI's discretion.
- Topical antimicrobial treatment is being used on the target wound at the time of subject enrollment, and the treatment will be continued. Note: Specific treatment used will be left to the PI's discretion.
- Target wound contains a malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careTreatment appropriate for wound condition | Other | WOUNDCHEK Bacterial Status negative, WOUNDCHEK Bacterial Status positive |
Primary outcome
Wound healing
Time frame: 12 weeks
Complete wound closure
1 secondary outcome
Wound size reduction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliza Lee, DPM principal investigator
Salem VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by Woundchek Laboratories BV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025; AzTrials last refreshed its copy on 29 Oct 2026.