Testing a new device to measure wound alkalinity in chronic ulcers
Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® pH Device as a Prognostic Tool in the Identification of Non-healing Chronic Wounds
This study is testing a new device to see if measuring the alkalinity of wounds can help understand why some chronic ulcers, like diabetic foot ulcers, don’t heal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Progenitec Inc. Industry-sponsored |
| Locations | 2 sites (Lake Success, New York and 1 other locations) |
| Trial ID | NCT04614038 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between wound alkalinity and the healing status of chronic ulcers, such as diabetic foot ulcers and pressure ulcers. Using the DETEC® pH device, researchers will assess the alkalinity of wound exudate collected from dressings during routine follow-up visits. Participants will be monitored over a 12-week period to determine if an alkaline environment correlates with non-healing wounds. The device's outputs will be recorded, but treatment decisions will not be influenced by the device's results.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic wounds that have been open for at least 30 days, such as diabetic foot ulcers or venous leg ulcers.
Not a fit: Patients with autoimmune diseases, malignancies, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for early identification of non-healing wounds, potentially improving patient outcomes.
How similar studies have performed: While the approach of using pH measurement in wound care is promising, this specific methodology with the DETEC® pH device is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lake Success, New York and 1 other locations
- Northwell Health Comprehensive Wound Healing Center — Lake Success, New York, United States (Recruiting)
- Complex Healthcare Solutions — Arlington, Texas, United States (Enrolling_by_invitation)
Study contacts
- Principal investigator: Wenjing Hu, Ph.D. — Progenitec Inc.
- Study coordinator: Wenjing Hu, Ph.D.
- Email: wenjing.hu@progenitec.com
- Phone: 682-365-8775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.