DETEC® pH Point of Care Wound Diagnostic Test

Diabetic Foot Ulcer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Chronic wounds fail to progress through normal wound healing phases in a timely manner which makes them non-healing over time. The inability to identify a slowly healing or non-healing wound early on can be detrimental to the patient's well-being. Currently, determination of non-healing wounds is based on the clinician's visual observation of wound size changes for 4 weeks. Many early studies have documented that chronic, non-healing, or infected wounds often reside in an alkaline state (pH > 7.2) while healing wounds are habitually associated with a non-alkaline and even acidic environment.

To reliably and continuously monitor wound alkalinity objectively, a portable, disposable, non-invasive, and non-contact device - DETEC® pH - was developed to indirectly assess the alkalinity of wounds by analyzing the wound exudate adsorbed on to freshly discarded wound dressings during the participants' routine follow-up visit. A follow-up visit and 7-21 days after the initial wound diagnosis and care, subjects will be screened and enrolled in this investigation based on the inclusion and exclusion criteria. Their wound dressings will be tested using the device. The device outputs and wound conditions will be recorded. The subjects' wounds will be managed using standard care by the provider at each visit. The device output will not be used to inform the treatment decision in this study.

At 12 weeks after initial wound diagnosis, the subjects will be required to present themselves for a follow-up/end of study wound healing status assessment.

The device outputs will then be compared to the clinical healing status of the wounds (healed or not healed) at week 12. For the study, a healed wound is defined as one that has achieved complete wound closure that is defined as skin re-epithelialization without drainage or dressing requirements (100% of the wound is covered and the surface is intact), as assessed by the treating clinician. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Wound, Non-Healed
• Wounds and Injuries

• NCT number: NCT04614038
• Study type: Observational
• Source: Progenitec Inc.
• Contact: Wenjing Hu, Ph.D.
• Phone: 682-365-8775
• Email: wenjing.hu@progenitec.com
• Status: Recruiting
• Start date: January 1, 2022
• Completion date: December 31, 2024