Ireland
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Recruiting Not applicable

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

NCT05496296 · tracked via the Priya Life Science USA tracker
Sponsor
ULURU Inc
Phase
Not applicable
Started
2023-04-30
Last updated
2025-11-20

Condition(s) studied

Pressure Ulcers Stage IIPressure Ulcers Stage IIIPressure Ulcer, Stage IV

Investigational drug(s) / intervention(s)

Altrazeal® Transforming Powder Dressing

Altrazeal® Transforming Powder Dressing: Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. 18 to 85 years of age; 2. Stage 2, 3, or 4 Pressure Injuries; 3. Wound exudate is mild to moderate; 4. No clinically active wound infection (clinical diagnosis); 5. Able and willing to provide written (not proxy) informed consent; 6. Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment. Exclusion Criteria: 1. Known allergy or hypersensitivity to TPD or its components; 2. Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1; 3. Heavily exudative wounds; 4. Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema \>0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge; 5. Poorly controlled diabetes with HgbA1C \>12 (as documented in the last 3 months); 6. Body Mass Index (BMI) \>45 kg/m2; 7. Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb); 8. Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \<0.7 on the affected limb, if wound is located on the limb); 9. Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study; 10. Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes; 11. Wounds with necrosis unable to undergo prior definitive debridement; 12. Fistulas; 13. Active gangrene; 14. Untreated HIV; 15. Currently pregnant or lactating; 16. Impending organ transplant; 17. Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients; 18. Unwilling or unable to comply with offloading recommendations; 19. If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because: 1. Unable to keep research appointments; 2. Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound); 3. Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes; 4. Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules; 5. Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study; 6. Not suitable for study participation. -

Primary outcome measure(s)

  • Number of wound dressing changes — 12 weeks
    The number of primary dressing changes for each treatment group will be compared.

Trial sites (14)

FacilityCityRegionStatus
San Diego VA San Diego California Recruiting
Medstar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
MedStar National Rehabilitation Hospital Washington D.C. District of Columbia Recruiting
Northwestern Medicine Chicago Illinois Active Not Recruiting
Medstar Franklin Square Medical Center Baltimore Maryland Recruiting
Medstar Good Samaritan Hospital Baltimore Maryland Recruiting
Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic Newark New Jersey Recruiting
Northwell Health System/Zucker School of Medicine Lake Success New York Recruiting
NYU Langone Hospital-Long Island Mineola New York Recruiting
James J. Peters VA Medical Center The Bronx New York Recruiting
Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion Valhalla New York Recruiting
University of Pittsburgh Medical Center (UPMC) Presbyterian Pittsburgh Pennsylvania Recruiting
VA North Texas Healthcare System Dallas Texas Recruiting
Michael E. DeBakey Houston VAMC Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05496296 on ClinicalTrials.gov ↗ ← All trials in the USA