DETEC® Esterase for Screening Wound Infection at Point of Care

Diabetic Foot Ulcer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

• NCT number: NCT04614870
• Study type: Observational
• Source: Progenitec Inc.
• Contact: Wenjing Hu, PhD
• Phone: 6823658775
• Email: wenjing.hu@progenitec.com
• Status: Recruiting
• Start date: May 1, 2022
• Completion date: December 31, 2024