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

ConditionWound Care

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorParaNano, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Subject's target treatment area has a surface area larger than 5 cm2.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Arm 1 - MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consentActive comparator 1 intervention

Group B: Arm 2 - MolecuLightDX™ or MolecuLight i:X™ imaging prior to applicationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Primary Endpoint:

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

Time frame

48 hours after screening

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ParaNano, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: