DETEC pH Point of Care Wound Diagnostic Test

  • STATUS
    Recruiting
  • End date
    Dec 22, 2022
  • participants needed
    450
  • sponsor
    Progenitec Inc.
Updated on 22 July 2021
diabetes
type 2 diabetes mellitus
ischemia
hemoglobin a1c
wound care
diabetic foot
a hemoglobin
wound dressing

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.

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.

Details
Condition Varicose Ulcer, Venous stasis, Decubitus Ulcer, Diabetic Foot, Bed Sores (Decubitus Ulcers), Diabetic Foot Ulcers, Pressure Ulcers, Pressure Ulcer, Wound, Non-Healed, diabetic foot ulcer, venous ulcers, venous ulcer, pressure sores, decubitus, bedsore, Wound, Non-Healed, Wound, Non-Healed, Wound, Non-Healed
Treatment DETEC® pH
Clinical Study IdentifierNCT04614038
SponsorProgenitec Inc.
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

Inclusion 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

Exclusion Criteria

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
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