Recruiting

DETEC® Esterase

Sponsor:

Progenitec Inc.

Code:

NCT04614870

Conditions

Diabetic Foot Ulcer

Venous Leg Ulcer

Pressure Ulcer

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

DETEC® Esterase

Study Details

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

Study ID

NCT04614870

Start date

May 1, 2022

Status verified date

Nov, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

DETEC® Esterase

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.

Primary outcome measure

  • Positive predictive value of the device in the determination of infection in wounds with clinical signs of infection [ Time Frame: 15 days from enrollment ]

Central Contacts and Locations

Central contacts

Wenjing Hu, PhD

6823658775wenjing.hu@progenitec.com

Locations

Complex Healthcare Solutions

Recruiting

Arlington, Texas, United States, 76018

Contacts

Jon Senkowsky, MD

JonSenkowsky@complexhs.com

Principal Investigator:

Jon Senkowsky, MD

More Information

Sponsor

Progenitec Inc.

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Progenitec Inc. on 2023-11-18.