A PAC Post-Market Clinical Study to Demonstrate Color Change in the WoundCue™ Kit When an Elevated Inhibitory Bacterial and/or Fungal Load is Present in a Wound
NCT ID: NCT07349485
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-21
2027-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm 1 - MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent
Subjects must have visible fluorescence when using MolecuLightDX™ or MolecuLight i:X™ imaging.
• Arm #1's Screening Visit requires that the standard of care MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent be obtained and used in the Study, as authorized by the Informed Consent.
HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye
HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye with a labile ester linkage, enzymatically cleavable by bacterial lipase released from clinically relevant strains of bacteria
Arm 2 - MolecuLightDX™ or MolecuLight i:X™ imaging prior to application
Arm #2's Visit #1 requires that the Clinical Site scans wound with MolecuLightDX™ or MolecuLight i:X™ imaging prior to application of the WoundCue™ Kit.
HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye
HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye with a labile ester linkage, enzymatically cleavable by bacterial lipase released from clinically relevant strains of bacteria
Interventions
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HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye
HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye with a labile ester linkage, enzymatically cleavable by bacterial lipase released from clinically relevant strains of bacteria
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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ParaNano, Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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NSR
Identifier Type: OTHER
Identifier Source: secondary_id
PRT-001
Identifier Type: -
Identifier Source: org_study_id
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