An observational study in Diabetic Foot Ulcer, Venous Leg Ulcer and Pressure Ulcer, sponsored by Progenitec Inc.. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Progenitec Inc. · Observational
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.
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:
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 186 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Progenitec Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with chronic wounds
Exclusion Criteria:
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.
Positive predictive value of the device in the determination of infection in wounds with clinical signs of infection
The primary endpoint is agreement in infected wound determination between device output and providers' adjudication in wounds with suspected infection.
Time frame: 15 days from enrollment
Positive predictive value of the device in the determination of infection in wounds with various patient and wound conditions
The secondary endpoint is identifying infection in wounds with various biometry and disease conditions (age, gender, race, wound size, wound locations, wound types, infection status, and clinical sites).
Time frame: 15 days from enrollment
Likelihood of infection
Another secondary endpoint is the likelihood of infection with positive and negative test results
Time frame: 15 days from enrollment
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Progenitec Inc.