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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye.
- Who it may be relevant to
- Registry conditions: Wound Care. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.
Interventions
- Diagnostic test 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
Primary outcome measures
- Primary Endpoint: [Time frame: 48 hours after screening]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07349485 · PRT-001 · NSR