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

NCT07349485 | Not Yet Recruiting

• 2 other identifiers: PRT-001NSR
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.

Conditions

Wound Care

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint:

  80% correlation (1:1) in detection of elevated inhibitory bacterial and/or fungal load by WoundCue™ Kit and confirmed by laboratory testing.

  48 hours after screening

Study Arms (2)

Arm 1 - MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent

ACTIVE COMPARATOR

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.

Diagnostic Test: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye

Arm 2 - MolecuLightDX™ or MolecuLight i:X™ imaging prior to application

ACTIVE COMPARATOR

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.

Diagnostic Test: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye

Interventions

HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye DIAGNOSTIC_TEST

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 1 - MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent; Arm 2 - MolecuLightDX™ or MolecuLight i:X™ imaging prior to application

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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

Sponsors & Collaborators

• ParaNano, Inc.: lead

Central Study Contacts

Chelsea Luxen

CONTACT

405-802-3482; cluxen@paranano.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01