Using DETEC® Esterase to detect infections in chronic wounds
Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® Esterase for the Detection of Infections in Chronic Wounds
This study is testing a new device to see if it can help find infections in chronic wounds like diabetic foot ulcers and pressure ulcers by checking for certain markers in the wound fluid.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Progenitec Inc. Industry-sponsored |
| Locations | 1 site (Arlington, Texas) |
| Trial ID | NCT04614870 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the DETEC® Esterase device's ability to identify infections in chronic wounds by analyzing leukocyte esterase levels in wound exudates. Patients with diabetic foot ulcers, venous leg ulcers, or pressure ulcers will have their wound dressings tested for esterase activity, which correlates with clinical signs of infection. The study aims to determine the device's sensitivity, specificity, and accuracy in detecting infections compared to clinical assessments by wound care specialists.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic wounds showing clinical signs of infection, such as diabetic foot ulcers, venous leg ulcers, or pressure ulcers.
Not a fit: Patients with autoimmune diseases, malignancies, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a rapid and reliable method for detecting infections in chronic wounds, improving patient outcomes.
How similar studies have performed: While the use of leukocyte esterase as a biomarker has been established in other contexts, this specific application in chronic wound infection detection is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Arlington, Texas
- Complex Healthcare Solutions — Arlington, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Wenjing Hu, PhD — Progenitec Inc.
- Study coordinator: Wenjing Hu, PhD
- Email: wenjing.hu@progenitec.com
- Phone: 6823658775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.