Condition: Pressure Ulcers Stage II · Pressure Ulcers Stage III · Pressure Ulcer, Stage IV · Sponsor: ULURU Inc.
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a "dressing, wound, hydrogel" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.
This description comes directly from the study's public registry record.
Kerry Wallace · 513 702 7536 · kwallace@altrazeal.com
Susan St. John, MSN · sstjohn@altrazeal.com
Always discuss trial participation with your own doctor first.
| San Diego VA | San Diego, California, United States | Recruiting |
| Medstar Georgetown University Hospital | Washington D.C., District of Columbia, United States | Recruiting |
| MedStar National Rehabilitation Hospital | Washington D.C., District of Columbia, United States | Recruiting |
| Northwestern Medicine | Chicago, Illinois, United States | Active Not Recruiting |
| Medstar Franklin Square Medical Center | Baltimore, Maryland, United States | Recruiting |
| Medstar Good Samaritan Hospital | Baltimore, Maryland, United States | Recruiting |
| Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic | Newark, New Jersey, United States | Recruiting |
| Northwell Health System/Zucker School of Medicine | Lake Success, New York, United States | Recruiting |
| NYU Langone Hospital-Long Island | Mineola, New York, United States | Recruiting |
| James J. Peters VA Medical Center | The Bronx, New York, United States | Recruiting |
| Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion | Valhalla, New York, United States | Recruiting |
| University of Pittsburgh Medical Center (UPMC) Presbyterian | Pittsburgh, Pennsylvania, United States | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05496296