Wound CareNCT07349485
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
A study testing HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye in people with Wound Care, run by ParaNano, Inc..
Trial summary
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Wound Care
- What is being tested?
- HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 21 Jan 2026to 20 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dyeDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint:
80% correlation (1:1) in detection of elevated inhibitory bacterial and/or fungal load by WoundCue™ Kit and confirmed by laboratory testing.
Measured: 48 hours after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start21 Jan 2026 (estimated)
- Primary completion21 Jan 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ParaNano, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349485
- Sponsor's protocol ID
- PRT-001
- Other IDs
- NSR
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07349485
- Acronym / sponsor ID
- PRT-001
- Conditions
- Wound Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ParaNano, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2026 (estimated)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent | Active comparator | Diagnostic Test: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dyeSubjects 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. |
| Arm 2 - MolecuLightDX™ or MolecuLight i:X™ imaging prior to application | Active comparator | Diagnostic Test: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dyeArm #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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Arm 1:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dyeHCy-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 | Diagnostic test | 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 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye in people with Wound Care, run by ParaNano, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsea Luxen (405-802-3482, cluxen@paranano.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: (time frame: 48 hours after screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.