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DETEC® Esterase for Screening Wound Infection at Point of Care

NCT04614870 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-11-18

No results posted yet for this study

Summary

This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during routine wound care. The output of the device is correlated with clinical determination of infection to assess the device efficacy in identifying presumptive infections.

Conditions

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer
  • Pressure Ulcer

Interventions

DIAGNOSTIC_TEST

DETEC® Esterase

DETEC® Esterase is a disposable diagnostic device that is used to indicate the presence or absence of infection based on the presence or absence of the evaluated level of leukocyte esterase by testing the freshly recovered wound dressing which are soaked with wound exudate.

Sponsors & Collaborators

  • Progenitec Inc.

    lead INDUSTRY

Principal Investigators

  • Wenjing Hu, PhD · Progenitec Inc.

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-05-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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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 NCT04614870 on ClinicalTrials.gov