RECRUITING

DETEC® Esterase for Screening Wound Infection at Point of Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® Esterase for the Detection of Infections in Chronic Wounds

Quick Facts

Study Start:2022-05-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04614870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult (21 years), male or female, inpatient/outpatient, presenting with a wound
  2. * 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),
  3. * 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
  4. * For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a hemoglobin A1C less than 10 percentage
  5. * Wound shows clinical signs of infection - pain, erythema, edema, heat, surrounding erythema, swelling, or purulent exudate
  1. * History of autoimmune disease/ acquired immunodeficiency syndrome/Hepatitis
  2. * Require treatment for primary or metastatic malignancy
  3. * Any contra-indication to routine wound care and/or monitoring
  4. * Women who are pregnant, lactating, or of childbearing potential and currently not taking adequate birth control
  5. * 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
  6. * Patients with a dry dressing

Contacts and Locations

Study Contact

Wenjing Hu, PhD
CONTACT
6823658775
wenjing.hu@progenitec.com

Principal Investigator

Wenjing Hu, PhD
PRINCIPAL_INVESTIGATOR
Progenitec Inc.

Study Locations (Sites)

Complex Healthcare Solutions
Arlington, Texas, 76018
United States

Collaborators and Investigators

Sponsor: Progenitec Inc.

  • Wenjing Hu, PhD, PRINCIPAL_INVESTIGATOR, Progenitec Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-05-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer
  • Pressure Ulcer