About this trial
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 criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Altrazeal® Transforming Powder Dressing
Treatment groups
Sponsors and collaborators
ULURU Inc.
Lead sponsor
United States Department of Defense
Collaborator