An observational study in Diabetic Foot Ulcer, Venous Leg Ulcer and Pressure Ulcer, sponsored by Progenitec Inc.. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Progenitec Inc. · Observational
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 450 is above the median of 100 across 186 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Progenitec Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants have shown no significant progress toward healing in 30 days and thus been diagnosed with chronic wounds.
Exclusion Criteria:
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.
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
Time frame: 12 weeks from enrollment
Effect of various patient biometry and wound conditions on non-healing status based on change in wound area over 12 weeks
The secondary effectiveness endpoint is healing or non-healing wounds over 12 weeks based on subject's age, race, initial wound size, wound location, wound type, clinical sites and presence or absence of infection
Time frame: 12 weeks from enrollment
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Progenitec Inc.