RECRUITING

DETEC® Esterase for Screening Wound Infection at Point of Care

Description

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 UlcerVenous Leg UlcerPressure Ulcer
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Related Conditions:

Diabetic Foot UlcerVenous Leg UlcerPressure Ulcer

Study Overview

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Study Details

Study overview

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.

Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® Esterase for the Detection of Infections in Chronic Wounds

DETEC® Esterase for Screening Wound Infection at Point of Care

Condition
Diabetic Foot Ulcer
Intervention / Treatment

-

Contacts and Locations

Arlington

Complex Healthcare Solutions, Arlington, Texas, United States, 76018

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult (21 years), male or female, inpatient/outpatient, presenting with a wound
  • * Chronic wound open for at least 30 days, including (Diabetic foot ulcers (DFU), Wagner grade 1 to 3), (Pressure ulcers, stage 2 to 4), (Venous leg ulcers (VLU), confirmed by venous duplex/Doppler),
  • * For wounds on a lower extremity (i.e. DFU, VLU) an ankle-brachial index (ABI) of greater than 0.6 for the affected leg to ensure ischemia will not impact healing
  • * For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a hemoglobin A1C less than 10 percentage
  • * Wound shows clinical signs of infection - pain, erythema, edema, heat, surrounding erythema, swelling, or purulent exudate
  • * History of autoimmune disease/ acquired immunodeficiency syndrome/Hepatitis
  • * Require treatment for primary or metastatic malignancy
  • * Any contra-indication to routine wound care and/or monitoring
  • * Women who are pregnant, lactating, or of childbearing potential and currently not taking adequate birth control
  • * Participation (less than 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the Investigator
  • * Patients with a dry dressing

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Progenitec Inc.,

Wenjing Hu, PhD, PRINCIPAL_INVESTIGATOR, Progenitec Inc.

Study Record Dates

2024-12-31