DETEC® Esterase for Screening Wound Infection at Point of Care

NCT04614870 | Unknown

• 1 other identifier: DETEC 002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  15 days from enrollment

Secondary Outcomes (2)

• Positive predictive value of the device in the determination of infection in wounds with various patient and wound conditions

  15 days from enrollment

• Likelihood of infection

  15 days from enrollment

Interventions

DETEC® Esterase DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with chronic wounds

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

Sponsors & Collaborators

• Progenitec Inc.: lead

Study Sites (1)

Complex Healthcare Solutions

Arlington, Texas, 76018, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Wenjing Hu, PhD

  Progenitec Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjing Hu, PhD

CONTACT

6823658775; wenjing.hu@progenitec.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: May 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)