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Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
NCT05496296 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Altrazeal® Transforming Powder Dressing
Study Locations (14)
New York
- Northwell Health System/Zucker School of Medicine — Lake Success
- NYU Langone Hospital-Long Island — Mineola
- James J. Peters VA Medical Center — The Bronx
- Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion — Valhalla
District of Columbia
- Medstar Georgetown University Hospital — Washington D.C.
- MedStar National Rehabilitation Hospital — Washington D.C.
Maryland
- Medstar Franklin Square Medical Center — Baltimore
- Medstar Good Samaritan Hospital — Baltimore
Texas
- VA North Texas Healthcare System — Dallas
- Michael E. DeBakey Houston VAMC — Houston
California
- San Diego VA — San Diego
Illinois
- Northwestern Medicine — Chicago
New Jersey
- Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic — Newark
Pennsylvania
- University of Pittsburgh Medical Center (UPMC) Presbyterian — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-04-30 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05496296
The ClinicalTrials.gov registry entry for NCT05496296 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ULURU, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pressure Ulcer, Stage IV appearing as the primary indexed condition, and to 1 intervention — of which Altrazeal® Transforming Powder Dressing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05496296 reports 14 study locations spanning 8 distinct geographic areas — top geographies include New York, District of Columbia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05496296 about?
NCT05496296 is a clinical study titled "Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries". 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 ...
What is the current status of trial NCT05496296?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-04-30. Estimated completion is 2026-12.
What conditions does trial NCT05496296 study?
This clinical trial studies the following conditions: Pressure Ulcer, Stage IV, Pressure Ulcers Stage II, Pressure Ulcers Stage III. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05496296?
The interventions under investigation include: Altrazeal® Transforming Powder Dressing (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05496296?
This trial is sponsored by ULURU, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05496296 being conducted?
This trial has 14 study locations across California, District of Columbia, Illinois, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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