Color-Changing dye could spot wound infections instantly
NCT ID NCT07349485
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new kit called WoundCue that uses a special dye to detect bacteria or fungi in wounds. The dye changes color when harmful germs are present. Researchers will check if the kit's color change matches lab test results in 50 people with wounds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WoundCue Kit (a dye that changes color in the presence of bacteria or fungi)
- What this could lead to
- If successful, this could provide a quick, simple way for doctors to identify wound infections without lab tests.
- What could go wrong
- This is a small, early-stage study with only 50 participants, so results may not apply to all wounds. The color change might not be accurate enough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Arm 1: Subjects will be considered qualified for enrollment if they meet the following criteria: Subjects and/or Legally Authorized Representative (LAR) must voluntarily provide written Informed Consent, consisting of reading, signing, and dating the Informed Consent document after the Principal Investigator, sub-Principal Investigator, or other designated Study Staff member has explained the Study procedures, risks, and contact information. Able and willing to comply with all Study requirements. Subject can be Male or Female but must be over 21 years of age. Subject is currently under the care of a Primary Care Physician. Subject has an anticipated survival of greater than two months. Subject has a moderate to high exudate wound that has visible fluorescence when using MolecuLightDX™ or MolecuLight i:X™ imaging. Arm 2: Subjects will be considered qualified for enrollment if they meet the following criteria: Subjects and/or Legally Authorized Representative (LAR) must voluntarily provide written Informed Consent, consisting of reading, signing, and dating the Informed Consent document after the Principal Investigator, sub-Investigator, or other designated Study Staff member has explained the Study procedures, risks, and contact information. Able and willing to comply with all Study requirements. Subject can be Male or Female but must be over 21 years of age. Subject is currently under the care of a Primary Care Physician. Subject has an anticipated survival of greater than two months. Subject has a moderate to high exudate wound. \*For this Study, moderate exudate is defined as a wound that may require a dressing change 2-3 times a week based on provider judgement. Heavy exudate is defined as a wound that may require a dressing change 4 or more times a week based on provider judgement. Exclusion Criteria: * Subject's target treatment area has a surface area larger than 5 cm2. Known sensitivity or allergy to the Study Device or adhesives/adhesive-related products. Current use of topical ointments, including over-the-counter products and prescription drugs, on or near the intended treatment area. Current use or recent history (within the past 14 days) of antibiotics, either oral, systemic, or topical. Undergoing therapy with another investigational agent that may affect the WoundCueTM Kit's performance within thirty (30) days of Study Visit 1 or planned participation overlapping with this Study. Women who are pregnant, breastfeeding, or intend to become pregnant during the course of the Study. Medical condition that, in the opinion of the Principal Investigator, would preclude safe Subject participation in the Study. Adults who, in the judgment of the Investigator, lack the capacity to provide informed consent for themselves
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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