DETEC® Esterase for Screening Wound Infection at Point of Care

Launched by PROGENITEC INC. · Oct 28, 2020

Keywords

ClinConnect Summary

This clinical trial, called the DETEC® Esterase study, is looking at a new way to help doctors determine if wounds, specifically diabetic foot ulcers, venous leg ulcers, and pressure ulcers, are infected. The study involves using a device that tests samples from the wound to see how well it can identify infections compared to the usual clinical assessments made by healthcare providers. By doing this, the researchers hope to find a quicker and more accurate method for diagnosing infections right at the point of care.

To be eligible for this study, participants must be adults aged 21 and older with a chronic wound that has been open for at least 30 days, and they should show signs of infection. This includes people with specific types of ulcers related to diabetes or pressure. Participants will have their wound dressings tested using the DETEC® Esterase device during their regular wound care visits. It's important to note that certain individuals, such as those with autoimmune diseases or who are pregnant, cannot participate. Overall, this study aims to improve wound care and help patients heal more effectively.

Gender

ALL

Eligibility criteria

• 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