DETEC® pH Point of Care Wound Diagnostic Test
Status unconfirmed
Conditions studied: Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
In brief
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.
Key facts
- Study ID
- NCT04614038
- Run by
- Progenitec Inc.
- People needed
- 450
- Starts
- 2022-01-01
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2023-11-18
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northwell Health Comprehensive Wound Healing Center — Lake Success, New York, United States (enrolling)
- Complex Healthcare Solutions — Arlington, Texas, United States
Full record on ClinicalTrials.gov
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