Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorULURU Inc.
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
This trial accepts healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Altrazeal® Transforming Powder Dressing
DevicePressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Standard of Care Dressing for Pressure InjuryActive comparator 1 intervention
Group B: Altrazeal® Transforming Powder DressingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of wound dressing changes
The number of primary dressing changes for each treatment group will be compared.
Time frame
12 weeksSecondary outcomes
1
Wound healing
Wound healing will be measured by using a ruler each week to report length and width of the wound. Percentage of wound area reduction will be calculated for each treatment group and compared.
Time frame
12 weeks2
Complications (problems) from treating the pressure wound
Subjects will be asked to report, will be questioned and observed (by the researchers) each study visit for any complications, problems or adverse events related to the study wound that they experience, such as maceration around the wound from the drainage, moisture, or dressing. Complications and adverse events will be compared during the course of the study
Time frame
12 weeks3
Pain in the wound and from dressing changes.
Subjects with sensation in the area of the wound will be asked to complete a validated visual analogue scale. This is a simple validated test asking the subject to rate their pain on a 0-10 point level, where 10 is the worst and 0 is no pain. Mean and median pain scores will be compared for each treatment group during the course of the study
Time frame
12 weeks4
Wound Quality of Life
Mean and median changes in validated Wound Quality of Life scores will be measured between groups during the course of the study
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
ULURU Inc.
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov