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Recruiting Not applicable Interventional Accepts healthy volunteers

Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

ClinicalTrials.gov ID: NCT05496296

Public ClinicalTrials.gov record NCT05496296. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 7:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05496296
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
ULURU Inc.
Industry
Enrollment
300 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 29, 2023
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026
Last update posted
Nov 19, 2025

2023 – 2026

United States locations

U.S. sites
14
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
San Diego VA San Diego California 92161 Recruiting
Medstar Georgetown University Hospital Washington D.C. District of Columbia 20007 Recruiting
MedStar National Rehabilitation Hospital Washington D.C. District of Columbia 20010 Recruiting
Northwestern Medicine Chicago Illinois 60611 Active, not recruiting
Medstar Franklin Square Medical Center Baltimore Maryland 21237 Recruiting
Medstar Good Samaritan Hospital Baltimore Maryland 21239 Recruiting
Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic Newark New Jersey 07103 Recruiting
Northwell Health System/Zucker School of Medicine Lake Success New York 11042 Recruiting
NYU Langone Hospital-Long Island Mineola New York 11501 Recruiting
James J. Peters VA Medical Center The Bronx New York 10468 Recruiting
Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion Valhalla New York 10595 Recruiting
University of Pittsburgh Medical Center (UPMC) Presbyterian Pittsburgh Pennsylvania 15213 Recruiting
VA North Texas Healthcare System Dallas Texas 75243 Recruiting
Michael E. DeBakey Houston VAMC Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05496296, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 19, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05496296 live on ClinicalTrials.gov.

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