DETEC Esterase for Screening Wound Infection at Point of Care

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    200
  • sponsor
    Progenitec Inc.
Updated on 26 January 2021

Summary

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

Description

Qualitative measures of leukocyte esterase have been used clinically as a biomarker to screen for various infectious diseases including urinary tract infections, peritonitis and joint infections. It is likely that wound infection is also accompanied with the elevation of leukocyte esterase in wound fluid and on the wound dressing. To test this hypothesis, the proposed device - DETEC Esterase - has been developed to detect elevated leukocyte esterase on wound exudates absorbed on the wound contacting surface of wound dressings. With increasing esterase levels, this coloration (from colorless/pink to dark purple) becomes more intense indicating infection.

Patients presenting themselves to the clinic with ulcer wounds will be assessed by the clinicians. Those with or without clinical signs and symptoms of a wound infection will be enrolled and recorded in the study. The participant's first visit can be concurrent with enrollment. During this visit, the leukocyte esterase on wounds will be assessed by testing wound exudate adsorbed on to participants' wound dressings using the DETEC Esterase device by a project nurse/tester not involved with subjects' wound management and the output recorded. Wounds will be managed by the clinicians who are blinded from the device output. Consequently, the clinician will send the wound fluids/tissue samples from patients for microbiological laboratory testing. Within 15 days following the first visit, the presence or absence of infection will then be adjudicated by the provider based on all information. The device output will then be correlated with this adjudication.

Details
Condition Varicose Ulcer, Venous stasis, Decubitus Ulcer, Diabetic Foot, Bed Sores (Decubitus Ulcers), Diabetic Foot Ulcers, Pressure Ulcers, Pressure Ulcer, diabetic foot ulcer, venous ulcers, venous ulcer, pressure sores, decubitus, bedsore
Treatment DETEC® Esterase
Clinical Study IdentifierNCT04614870
SponsorProgenitec Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 21 yrs?
Gender: Male or Female
Do you have any of these conditions: Pressure Ulcers or Pressure Ulcer or diabetic foot ulcer or Bed Sores (Decubitus Ulcers) or venous ulcers or decubitus or bedsore or Decubitus Ulcer o...?
Do you have any of these conditions: pressure sores or Bed Sores (Decubitus Ulcers) or diabetic foot ulcer or bedsore or Venous stasis or decubitus or Pressure Ulcers or venous ulcer or D...?
Adult (21 years), male or female, inpatient/outpatient, presenting with a wound
Chronic wound of multiple etiologies for at least 30 days, including (Diabetic foot ulcers, Wagner grade 1 to 3), (Pressure ulcers, stage 2 to 4), (Venous leg ulcers, confirmed by venous duplex)
For leg or foot ulcers (e.g. DFU, VLU) an ankle-brachial index (ABI) measured on the limb with the ulcer of greater than 0.6
For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a hemoglobin A1C less than 12 percentage (or less than 107.65 millimoles per mole)

Exclusion Criteria

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 not currently taking adequate birth control
Scheduled for or likely to have significant surgical intervention to the studied wound (e.g. skin graft or flap, amputation) during the study period
With a life expectancy of less than 6 months
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
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