NCT05496296 · ULURU Inc.
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
What this study is about
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.
View original scientific 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 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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
- San Diego, California
- Washington D.C., District of Columbia
- Chicago, Illinois
- Baltimore, Maryland
- Newark, New Jersey
- Lake Success, New York
- Mineola, New York
- The Bronx, New York
- Valhalla, New York
- Pittsburgh, Pennsylvania
- Dallas, Texas
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2025 · Source of record for eligibility and locations