DETEC® pH Point of Care Wound Diagnostic Test

Launched by PROGENITEC INC. · Oct 28, 2020

Keywords

ClinConnect Summary

The DETEC® pH Point of Care Wound Diagnostic Test study aims to understand how the pH level, or acidity, of chronic wounds affects their healing. Researchers believe that wounds with a higher pH (more alkaline) may have a harder time healing over 12 weeks of care. This trial is open to adults aged 21 and older who have chronic wounds, such as diabetic foot ulcers, pressure ulcers, or venous leg ulcers, that have been open for at least 30 days. Participants should also have certain health conditions, like diabetes, that meet specific criteria.

If you decide to take part in this study, you'll be monitored over 12 weeks while receiving standard wound care. Some people may not be eligible to join, especially if they have certain medical conditions, are pregnant, or are scheduled for significant surgeries during the study period. This trial is currently recruiting participants, and it offers a chance to contribute important information that could help improve wound care for others in the future.

Gender

ALL

Eligibility criteria

• 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