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

January 27, 2026 updated by: ParaNano, Inc.
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 - MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint:
Time Frame: 48 hours after screening
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ParaNano, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 21, 2026

Primary Completion (Estimated)

January 21, 2027

Study Completion (Estimated)

November 20, 2027

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PRT-001
  • NSR (Other Identifier: ParaNano)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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