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Transforming Powder Dressing (Altrazeal®) versus NPIAP-Recommended Dressings for Stage 2–4 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

Not applicable Interventional ULURU Inc. · NCT05496296

This will test whether a transforming powder dressing (Altrazeal®) helps adults with stage 2–4 pressure injuries heal better, need fewer dressing changes, or have less pain than standard NPIAP-recommended dressings.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorULURU Inc. Industry-sponsored
Locations14 sites (San Diego, California and 13 other locations)
Trial IDNCT05496296 on ClinicalTrials.gov

What this trial studies

Adults with stage 2, 3, or 4 pressure injuries will be randomized in an open-label trial to receive either standard of care dressings per NPIAP guidance or the Altrazeal® Transforming Powder Dressing (TPD). Treatment can occur while hospitalized or as an outpatient, and participants attend up to 12 visits over 12 weeks. The study’s primary aim is to see if dressing-change frequency can be reduced with Altrazeal®, and secondary outcomes include wound healing, complications, pain, quality of life, and overall costs. Altrazeal® is a conformable powder hydrogel dressing with an extended wear time of up to 30 days and is used with secondary dressings as needed.

Who should consider this trial

Good fit: Adults aged 18–85 with stage 2, 3, or 4 pressure injuries that have mild to moderate exudate, no clinical wound infection, are clinically stable, and can give informed consent are ideal candidates.

Not a fit: Patients with heavily exudative wounds, active wound infection, unstageable or stage 1 or deep tissue pressure injuries, known allergy to the dressing, BMI >45, poorly controlled diabetes (A1C >12), or venous stasis/lymphedema are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the dressing could reduce how often dressings must be changed, lower pain and complication rates, and decrease overall wound-care costs.

How similar studies have performed: Powder and hydrogel dressings including Altrazeal® have case reports and device-use literature suggesting benefit, but randomized comparisons against NPIAP-recommended standard care are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 wounds;
4. 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;
5. Poorly controlled diabetes with HgbA1C \>12 (as documented in the last 3 months);
6. Body Mass Index (BMI) \>45 kg/m2;
7. Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
8. Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \<0.7 on the affected limb, if wound is located on the limb);
9. Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
10. 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;
11. Wounds with necrosis unable to undergo prior definitive debridement;
12. Fistulas;
13. Active gangrene;
14. Untreated HIV;
15. Currently pregnant or lactating;
16. Impending organ transplant;
17. Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
18. Unwilling or unable to comply with offloading recommendations;
19. If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:

    1. Unable to keep research appointments;
    2. Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);
    3. Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;
    4. Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;
    5. Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;
    6. Not suitable for study participation. -

Where this trial is running

San Diego, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pressure Ulcers Stage IIPressure Ulcers Stage IIIPressure Ulcer, Stage IVWound careQuality of lifePain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.