DETEC® Esterase for Screening Wound Infection at Point of Care

Status unconfirmed

Conditions studied: Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer

In brief

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.

Key facts

Study ID

NCT04614870

Run by

Progenitec Inc.

People needed

200

Starts

2022-05-01

Expected to finish

2024-12-31

Last updated by the study team

2023-11-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Complex Healthcare Solutions — Arlington, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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