DETEC® pH Point of Care Wound Diagnostic Test

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

DETEC® pH Point of Care Wound Diagnostic Test

Condition
Diabetic Foot Ulcer
Intervention / Treatment

-

Contacts and Locations

Lake Success

Northwell Health Comprehensive Wound Healing Center, Lake Success, New York, United States, 11042

Arlington

Complex Healthcare Solutions, Arlington, Texas, United States, 76018

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.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Progenitec Inc.,

Wenjing Hu, Ph.D., PRINCIPAL_INVESTIGATOR, Progenitec Inc.

Study Record Dates

2024-12-31