RecruitingNot ApplicableNCT05496296

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

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


Sponsor

ULURU Inc.

Enrollment

300 participants

Start Date

Apr 30, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new wound dressing powder (Transforming Powder Dressing, or TPD) against standard-of-care dressings for treating Stage 2, 3, or 4 pressure injuries (bedsores) in adults. You may be eligible if: - You are between 18 and 85 years old - You have a Stage 2, 3, or 4 pressure injury - Your wound has mild to moderate drainage - Your wound does not have an active infection - You are able to give written consent and follow study visits - You are medically stable You may NOT be eligible if: - You have a known allergy to the study dressing or its ingredients - Your pressure injury is unstageable, deep tissue, or Stage 1 - Your wound is heavily draining - You have an active wound infection - You have poorly controlled diabetes (HbA1c over 12) - Your BMI is above 45 - You have vascular disease or lymphedema in an affected limb - You have severe limb ischemia (ABI below 0.7) - You recently received or will receive immunosuppressants or biologics - You are using concurrent treatments like hyperbaric oxygen or skin substitutes - You have wound necrosis that cannot be removed - You have fistulas, gangrene, or untreated HIV - You are currently pregnant or breastfeeding - You are awaiting an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAltrazeal® 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


Locations(14)

San Diego VA

San Diego, California, United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Northwestern Medicine

Chicago, Illinois, United States

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States

Medstar Good Samaritan Hospital

Baltimore, Maryland, United States

Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic

Newark, New Jersey, United States

Northwell Health System/Zucker School of Medicine

Lake Success, New York, United States

NYU Langone Hospital-Long Island

Mineola, New York, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion

Valhalla, New York, United States

University of Pittsburgh Medical Center (UPMC) Presbyterian

Pittsburgh, Pennsylvania, United States

VA North Texas Healthcare System

Dallas, Texas, United States

Michael E. DeBakey Houston VAMC

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05496296


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