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New powder dressing could cut bedsore dressing changes

NCT ID NCT05496296

Disease control Sponsor: ULURU Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special powder dressing called Altrazeal for treating bedsores (pressure ulcers) in stages 2, 3, and 4. About 300 adults will either get this new dressing or standard care. The main goal is to see if the new dressing needs fewer changes and helps wounds heal better over 12 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. -

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Conditions

The condition(s) this trial relates to.

decubitus ulcer Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pressure ulcer, stage IV Pressure ulcers stage II Pressure ulcers stage III

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • James J. Peters VA Medical Center

    RECRUITING

    The Bronx, New York, 10468, United States

  • MedStar National Rehabilitation Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Medstar Franklin Square Medical Center

    RECRUITING

    Baltimore, Maryland, 21237, United States

  • Medstar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Medstar Good Samaritan Hospital

    RECRUITING

    Baltimore, Maryland, 21239, United States

  • Michael E. DeBakey Houston VAMC

    RECRUITING

    Houston, Texas, 77030, United States

  • NYU Langone Hospital-Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • Northwell Health System/Zucker School of Medicine

    RECRUITING

    Lake Success, New York, 11042, United States

  • Northwestern Medicine

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic

    RECRUITING

    Newark, New Jersey, 07103, United States

  • San Diego VA

    RECRUITING

    San Diego, California, 92161, United States

  • University of Pittsburgh Medical Center (UPMC) Presbyterian

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • VA North Texas Healthcare System

    RECRUITING

    Dallas, Texas, 75243, United States

  • Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion

    RECRUITING

    Valhalla, New York, 10595, United States

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