DETEC Esterase for Screening Wound Infection at Point of Care

  • STATUS
    Recruiting
  • End date
    Dec 21, 2022
  • participants needed
    200
  • sponsor
    Progenitec Inc.
Updated on 21 July 2021
diabetes
heat
type 2 diabetes mellitus
ischemia
hemoglobin a1c
wound care
diabetic foot
a hemoglobin
wound dressing

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.

Description

There is no commercial available device to diagnosze infection in chronic wounds. Since qualitative measures of leukocyte esterase (LE) 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 LE can also be used a a biomarker to screen infection in chronic wounds. To test this hypothesis, an investigational device - DETEC Esterase - has been developed to detect elevated LE in wound exudates absorbed wound dressings. With increasing LE levels, this coloration becomes more intense (from colorless/pink to dark purple) indicating infection.

The overall goals of the study are as follows:

  1. To assess the efficacy of DETEC Esterase in detecting ulcer wound infection by comparing device output with the wound care specialist's final determination of infection
  2. To evaluate the effect of the subject's age, race, wound size, location, type, and clinical site on the device's ability to identify non-healing wounds.
  3. To study the sensitivity, specificity, and accuracy of DETEC Esterase in assessing infection by testing discarded wound dressings with varying levels of esterase activities.

Patients presenting themselves to the clinic with ulcer wounds will be assessed by the clinicians. Those with at least one clinical sign and symptom 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 participants' wound dressings will be tested using 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 may adjudicate the presence or absence of infection based on all available information to make a clinical diagnosis of infection. The device determination of presumptive infection will then be compared with the results of the doctor's 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 on21 July 2021

Eligibility

Yes No Not Sure

Inclusion 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

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 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
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