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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• San Diego VA
  San Diego, California, United States Recruiting
• Medstar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting
• MedStar National Rehabilitation Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Medstar Franklin Square Medical Center
  Baltimore, Maryland, United States Recruiting
• Medstar Good Samaritan Hospital
  Baltimore, Maryland, United States Recruiting
• Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic
  Newark, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Saxe Johathan, MD — Altrazeal Life Sciences Inc
• Study coordinator: Kerry Wallace
• Email: kwallace@altrazeal.com
• Phone: 513 702 7536

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing pressure injuries in hospitalized infants, children, and young people (0–19 years) with darker skin tones

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• Italian validation of the Braden QD pressure-injury risk scale for newborns in the NICU

  This project will test whether the Italian Braden QD Scale can reliably identify newborns in the NICU who are at risk of developing pressure injuries.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.