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

Recruiting now · Not applicable

Conditions studied: Pressure Ulcers Stage II, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV

In brief

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.

Key facts

Study ID

NCT05496296

Run by

ULURU Inc.

People needed

300

Starts

2023-04-30

Expected to finish

2026-12-01

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 85 years of age;
• Stage 2, 3, or 4 Pressure Injuries;
• Wound exudate is mild to moderate;
• No clinically active wound infection (clinical diagnosis);
• Able and willing to provide written (not proxy) informed consent;
• Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.

You may not qualify if…

• Known allergy or hypersensitivity to TPD or its components;
• Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
• Heavily exudative wounds;
• 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;
• Poorly controlled diabetes with HgbA1C >12 (as documented in the last 3 months);
• Body Mass Index (BMI) >45 kg/m2;
• Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
• Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) <0.7 on the affected limb, if wound is located on the limb);
• Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
• 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;
• Wounds with necrosis unable to undergo prior definitive debridement;
• Fistulas;
• Active gangrene;
• Untreated HIV;
• Currently pregnant or lactating;
• Impending organ transplant;
• Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
• Unwilling or unable to comply with offloading recommendations;
• If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:
• Unable to keep research appointments;
• Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);
• Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;
• Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;
• Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;
• Not suitable for study participation. -

Where it is running

• Michael E. DeBakey Houston VAMC — Houston, Texas, United States (enrolling)
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States (enrolling)
• San Diego VA — San Diego, California, United States (enrolling)
• Medstar Franklin Square Medical Center — Baltimore, Maryland, United States (enrolling)
• Medstar Good Samaritan Hospital — Baltimore, Maryland, United States (enrolling)
• Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic — Newark, New Jersey, United States (enrolling)
• Northwell Health System/Zucker School of Medicine — Lake Success, New York, United States (enrolling)
• NYU Langone Hospital-Long Island — Mineola, New York, United States (enrolling)
• James J. Peters VA Medical Center — The Bronx, New York, United States (enrolling)
• Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion — Valhalla, New York, United States (enrolling)
• University of Pittsburgh Medical Center (UPMC) Presbyterian — Pittsburgh, Pennsylvania, United States (enrolling)
• VA North Texas Healthcare System — Dallas, Texas, United States (enrolling)
• Northwestern Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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