DETEC® pH Point of Care Wound Diagnostic Test

Summary

Participation Requirements

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 ba...

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. It is also well established that chronic, non-healing, or infected wounds often reside in an alkaline state 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' follow-up visit. Subjects with chronic wounds will be screened and enrolled in this investigation based on the inclusion and exclusion criteria. The study will include enrollment and initial assessment visit, subsequent visits when the device will be tested, and end of study wound healing status assessment at 12 weeks. The subjects' wounds will be managed using standard care by the provider at each visit. The device outputs and wound conditions will be recorded. The clinicians will be blinded to the device outputs that will be compared to the clinical non-healing status of the wounds assessed for up to 12 weeks after the subjects' enrollment. For the study, a non-healed wound is defined as one that has failed to achieve 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.

Tracking Information