Wound HealNCT06501105
Performance of WOUNDCHEK Bacterial Status
An observational study of Wound Heal, 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) when the test result is used to inform treatment decisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- WOUNDCHEK Bacterial Status
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to Dec 2024
- 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: 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.
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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northwell Health Comprehensive Wound Healing & Hyperbaric Center
Lake Success, New York, 11042
Alisha Oropallo, MD, 516-233-3780, aoropallo@northwell.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Wound Heal
- Being tested
- WOUNDCHEK Bacterial Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOUNDCHEK Bacterial StatusDevice
Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.
| Study group | Role | What they receive |
|---|---|---|
| WOUNDCHEK Bacterial Status positive | Wounds positive for bacterial protease activity that may delay healing if untreated. Pre- and post-test treatment plan recorded. Receives: Device: WOUNDCHEK Bacterial Status | |
| WOUNDCHEK Bacterial Status negative | Wounds negative for bacterial protease activity. Pre- and post-test treatment plan recorded. Receives: Device: WOUNDCHEK Bacterial Status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
Adverse events
There will be no device related serious adverse events (SAE) or unanticipated adverse device effects (UADE).
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 posted15 Jul 2024
- Study start18 Jun 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woundchek Laboratories BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501105
- Sponsor's protocol ID
- PROT-2023-002
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. 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
- ClinicalTrials.gov ID
- NCT06501105
- Acronym / sponsor ID
- PROT-2023-002
- Conditions
- Wound Heal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Woundchek Laboratories BVIndustry (pharma, biotech, devices)
- Collaborators
- Northwell Health
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Jul 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) 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WOUNDCHEK Bacterial Status positive | – | Device: WOUNDCHEK Bacterial StatusWounds positive for bacterial protease activity that may delay healing if untreated. Pre- and post-test treatment plan recorded. |
| WOUNDCHEK Bacterial Status negative | – | Device: WOUNDCHEK Bacterial StatusWounds negative for bacterial protease activity. Pre- and post-test treatment plan recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
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 (7 listed)
- Subject does not meet inclusion criteria.
- 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
- .
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 |
|---|---|---|
| WOUNDCHEK Bacterial StatusLateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid. | Device | WOUNDCHEK Bacterial Status negative, WOUNDCHEK Bacterial Status positive |
Primary outcome
Healing rate and mean percent wound area reduction
Time frame: 12 weeks
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
2 secondary outcomes
WOUNDCHEK Bacterial Status negative wound healing rate
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No. No plan to share IPD.
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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.
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 Heal, 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 7 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: status not confirmed, as of the sponsor's last update on 15 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack Wilkens, MBA (305 926 8380, jack.wilkens@woundchek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate and mean percent wound area reduction (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 15 Jul 2024.