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
ULURU Inc.
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.
Description
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 with redness to full thickness wounds with deep tissue loss and exposed bone. This study will focus on patients with stage 2, stage 3 and stage 4 pressure injury wounds. It will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® Transforming Powder Dressing (TPD). Altrazeal® is a Class 1, 501(k) exempt medical device listed wi…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
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 w…
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 VASan Diego, California
- Medstar Georgetown University HospitalWashington D.C., District of Columbia
- MedStar National Rehabilitation HospitalWashington D.C., District of Columbia
- Northwestern MedicineChicago, Illinois
- Medstar Franklin Square Medical CenterBaltimore, Maryland
- Medstar Good Samaritan HospitalBaltimore, Maryland