A PAC Post-Market Clinical Study to Demonstrate Color Change in the WoundCue™ Kit When an Elevate… (NCT07349485) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
50 participantsStarted 2026-01-21
Plain-language summary
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 an…