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
Starting soon · Not applicable
Conditions studied: Wound Care
In brief
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.
Key facts
- Study ID
- NCT07349485
- Run by
- ParaNano, Inc.
- People needed
- 50
- Starts
- 2026-01-21
- Expected to finish
- 2027-11-20
- Last updated by the study team
- 2026-01-29
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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