Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation.
Joshua S Mervis, Tania J Phillips
https://pubmed.ncbi.nlm.nih.gov/30664905Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID05496296
Randomized Study Comparing Transforming Powder Dressing to 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
N/A
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, also known as pressure ulcers, affect over 2.5 million people in the United States and range from intact skin to severe wounds with deep tissue loss. This study focuses on patients with stage 2, 3, and 4 pressure injuries and aims to compare the standard care treatment recommended by the National Pressure Injury Advisory Panel to a new treatment using Altrazeal ae Transforming Powder Dressing, a wound hydrogel device. The study evaluates whether dressing changes can be reduced and compares wound healing, complications, pain, quality of life, and costs between the two treatments. Participants will be randomly assigned to one of two groups: one receiving standard wound dressings such as hydrocolloid, hydrogel, foam, or negative pressure therapy, and the other receiving the Altrazeal ae Transforming Powder Dressing, which conforms to the wound and protects it from bacteria. Altrazeal ae can remain on the wound for up to 30 days and is topped off as needed during visits. Both groups receive treatments over 12 consecutive weeks, with the option to end earlier if the wound heals. During the study, participants will attend up to 12 visits over 12 weeks for wound evaluations including cleaning, photographs, and measurements. They will also complete pain assessments, quality of life surveys, and questionnaires about wound care and offloading device use. Researchers will monitor dressing changes, healing progress, complications, pain, and quality of life. At study end, participants will complete a satisfaction survey about the wound dressing experience.
CONDITIONS
Brief Title
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Who Can Participate
Age: 18Years - 85Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Between 18 and 85 years old
- Have stage 2, 3, or 4 pressure injuries
- Wound drainage is mild to moderate
- No active wound infection
- Able and willing to provide written informed consent
- Clinically stable based on medical history, vital signs, physical exam, and labs
You will not qualify if you...
- Allergy or sensitivity to the transforming powder dressing or its components
- Pressure injuries that are unstageable, deep tissue injury, or stage 1
- Wounds with heavy drainage
- Wound infection defined by specific signs such as swelling, redness over 0.5 cm, tenderness, warmth, or pus
- Poorly controlled diabetes with hemoglobin A1C over 12 in the last 3 months
- Body mass index over 45 kg/m2
- Venous stasis disease or lymphedema in the affected limb if wound is on a limb
- Moderate to severe chronic limb ischemia with ankle brachial index below 0.7 if wound is on a limb
- Use of immunosuppressive or biologic drugs in the last 6 weeks or expected during the study
- Use of treatments like hyperbaric oxygen, electrical stimulation, ultrasound, or skin substitutes during the study
- Wounds with necrosis that cannot be debrided
- Presence of fistulas or active gangrene
- Untreated HIV infection
- Currently pregnant or breastfeeding
- Impending organ transplant
- Vulnerable populations including prisoners, children, cognitively impaired, unconscious, or illiterate patients
- Unable or unwilling to follow offloading recommendations
- Poor candidate due to inability to keep appointments, uncontrolled incontinence, recent participation in another study, active substance abuse, or other health risks as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 12 weeks or until the wound is healed
Participants receive either the standard of care dressings or Altrazeal® Transforming Powder Dressing for their pressure injuries. Wounds are evaluated, cleaned, measured, and dressed during visits.
Weekly visits for up to 12 weeks
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
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Research Team
K
Kerry Wallace
S
Susan St. John, MSN
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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Published Research Related To This Trial
Health-related quality of life in hospital inpatients with pressure ulceration: assessment using generic health-related quality of life measures.
Holly N Essex, Michael Clark, Joyce Sims...
https://pubmed.ncbi.nlm.nih.gov/19903301Health-Related Quality of Life in Elderly Patients With Pressure Ulcers in Different Care Settings.
Diba Maria Sebba Tosta de Souza, Daniela Francescato Veiga, Ivan Dunshee de Abranches Oliveira Santos...
https://pubmed.ncbi.nlm.nih.gov/26135820