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 range

21 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Endpoint:

Timeframe: 48 hours after screening

Trial details

NCT IDNCT07349485

SponsorParaNano, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-21

Contact for this trial

Chelsea Luxen

405-802-3482 cluxen@paranano.com

View on ClinicalTrials.gov More Wound Care trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.