DETEC® pH Point of Care Wound Diagnostic Test (NCT04614038) | Clinical Trial Compass
UnknownNot Applicable
DETEC® pH Point of Care Wound Diagnostic Test
United States450 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Non-healing status based on change in wound area over 12 weeks