RECRUITING

DETEC® pH Point of Care Wound Diagnostic Test

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

The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care.

Official Title

Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® pH Device as a Prognostic Tool in the Identification of Non-healing Chronic Wounds

Quick Facts

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

Study ID

NCT04614038

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
  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. * Scheduled for or likely to have significant surgical intervention to the studied wound (e.g. skin graft or flap, amputation) during the study period.
  6. * With a life expectancy of fewer than 6 months
  7. * 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
  8. * Patients with a dry dressing

Contacts and Locations

Study Contact

Wenjing Hu, Ph.D.
CONTACT
682-365-8775
wenjing.hu@progenitec.com

Principal Investigator

Wenjing Hu, Ph.D.
PRINCIPAL_INVESTIGATOR
Progenitec Inc.

Study Locations (Sites)

Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, 11042
United States
Complex Healthcare Solutions
Arlington, Texas, 76018
United States

Collaborators and Investigators

Sponsor: Progenitec Inc.

  • Wenjing Hu, Ph.D., 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 Date2022-01-01
Study Completion Date2024-12-31

Study Record Updates

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

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer
  • Pressure Ulcer
  • Wound, Non-Healed