DETEC® pH Point of Care Wound Diagnostic Test

NCT04614038 | Unknown

• 1 other identifier: DETEC 001
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Non-healing status based on change in wound area over 12 weeks

  The primary endpoint is non-healing wounds (that do not have 100 percent wound closure) at the end of 12 weeks

  12 weeks from enrollment

Secondary Outcomes (1)

• Effect of various patient biometry and wound conditions on non-healing status based on change in wound area over 12 weeks

  12 weeks from enrollment

Interventions

DETEC® pH DIAGNOSTIC_TEST

DETEC® pH is a disposable diagnostic device that is used to indicate the alkalinity of the wound by testing wound exudate adsorbed onto wound dressing.

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 have shown no significant progress toward healing in 30 days and thus been diagnosed 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

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
• 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

Sponsors & Collaborators

• Progenitec Inc.: lead

Study Sites (2)

Northwell Health Comprehensive Wound Healing Center

Lake Success, New York, 11042, United States

RECRUITING

Complex Healthcare Solutions

Arlington, Texas, 76018, United States

ENROLLING BY INVITATION

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Wounds and Injuries

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, Ph.D.

  Progenitec Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjing Hu, Ph.D.

CONTACT

682-365-8775; 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 22, 2020
• First Posted: November 3, 2020
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (2)