NCT04614870

DETEC® Esterase for Screening Wound Infection at Point of Care

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Progenitec Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot Ulcer
• Venous Leg Ulcer
• Pressure Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-05-31
• Completion: 2024-12-31
• First posted: 2020-11-04
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States