Actively Recruiting
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Led by ULURU Inc. · Updated on 2025-11-20
300
Participants Needed
14
Research Sites
187 weeks
Total Duration
On this page
Sponsors
U
ULURU Inc.
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 85 years of age
- Have stage 2, 3, or 4 pressure injuries
- Wound has mild to moderate fluid (exudate)
- No active wound infection based on clinical diagnosis
- Able and willing to provide written informed consent
- Clinically stable based on medical history, vital signs, physical exam, and lab tests before enrollment
You will not qualify if you...
- Allergy or sensitivity to Transforming Powder Dressing or its components
- Pressure injuries that are unstageable, deep tissue injuries, or stage 1
- Wounds with heavy fluid (exudate)
- Wound infection with at least two signs: swelling, redness over 0.5 cm, tenderness, warmth, or pus
- Poorly controlled diabetes with HgbA1C over 12 in last 3 months
- Body Mass Index over 45 kg/m2
- Venous stasis disease or lymphedema in the affected limb (if wound on limb)
- Moderate to severe chronic limb ischemia (ABI less than 0.7) on affected limb (if wound on limb)
- Received immunosuppressive or biologic treatments in last 6 weeks or expected during study
- Receiving certain other treatments (e.g., hyperbaric oxygen, topical oxygen, electrical stimulation) during study
- Wounds with necrosis that cannot be debrided
- Presence of fistulas
- Active gangrene
- Untreated HIV infection
- Currently pregnant or lactating
- Awaiting organ transplant
- Vulnerable populations including prisoners, children, cognitively impaired, unconscious, or illiterate patients
- Unwilling or unable to follow offloading recommendations
- Considered poor candidate by investigator due to appointment issues, severe incontinence, recent other studies, substance abuse, health risks, or other suitability concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
San Diego VA
San Diego, California, United States, 92161
Actively Recruiting
2
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
3
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Northwestern Medicine
Chicago, Illinois, United States, 60611
Active, Not Recruiting
5
Medstar Franklin Square Medical Center
Baltimore, Maryland, United States, 21237
Actively Recruiting
6
Medstar Good Samaritan Hospital
Baltimore, Maryland, United States, 21239
Actively Recruiting
7
Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic
Newark, New Jersey, United States, 07103
Actively Recruiting
8
Northwell Health System/Zucker School of Medicine
Lake Success, New York, United States, 11042
Actively Recruiting
9
NYU Langone Hospital-Long Island
Mineola, New York, United States, 11501
Actively Recruiting
10
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
11
Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion
Valhalla, New York, United States, 10595
Actively Recruiting
12
University of Pittsburgh Medical Center (UPMC) Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
13
VA North Texas Healthcare System
Dallas, Texas, United States, 75243
Actively Recruiting
14
Michael E. DeBakey Houston VAMC
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kerry Wallace
CONTACT
S
Susan St. John, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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