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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • ParaNano, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-21
Primary Completion
2027-01-21
Completion
2027-11-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349485 on ClinicalTrials.gov