Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
NCT ID: NCT05496296
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-04-30
2026-12-31
Brief Summary
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Detailed Description
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This study will focus on patients with stage 2, stage 3 and stage 4 pressure injury wounds. It will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® Transforming Powder Dressing (TPD). 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. Altrazeal® is a powder dressing that conforms to the wound, covering and protecting it, shielding the wound from bacteria. Altrazeal® is used in conjunction with a secondary dressing when needed.
The primary aim of the study is to evaluate whether dressing changes can be reduced during treatment of pressure injuries. The study will also compare wound healing between the group receiving Altrazeal® and the group receiving standard of care dressings, as well as complications, pain, quality of life, and overall costs between the two groups.
Subjects will be randomized into 2 groups, standard of care and Altrazeal®. Half of the subjects will receive current standard of care treatment, and the other half will receive treatment with Altrazeal®. This is an open-label study, meaning that both the subject and the treatment provider will know what study group the subject has been randomized to.
The first visit will be the screening visit to ensure patients meet eligibility criteria. Patients can be either an outpatient or hospitalized. Written informed consent will be obtained during this visit. A wound evaluation will be performed, and laboratory work ordered, if not done recently.
Once identified as meeting study criteria, the next visit is Baseline Visit, where randomization will occur and the first treatment will take place. Participants will be evaluated for 12 additional consecutive weeks, receiving wound evaluation, measurements, and getting treatment for the wound. A pain evaluation, quality of life survey related to having a wound, questionnaire regarding additional wound care performed between study visits. Participants will also answer questions regarding how much offloading devices or maneuvers were utilized, medications taken, and if any complications developed related to their wound care.
If the wound is healed prior to 12 weeks, the study will end when the wound is healed. Otherwise, the study will go on for 12 consecutive weeks. At the end of the study, the participant will be asked to complete a Subject Satisfaction Survey, answering questions regarding how the wound dressing worked for them. The surveys should take 5-10 minutes to complete.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Standard of Care Dressing for Pressure Injury
Standard wound dressings recommended by the National Pressure Injury Advisory Panel (NPIAP), according to the wound stage, will be utilized to treat pressure injuries. These include hydrocolloid, hydrogel, polymeric membranes, foam, collagen dressings, and negative pressure wound therapy. Dressings will be changed according to wound conditions, and type of dressing selected.
Altrazeal® Transforming Powder Dressing
Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm
Altrazeal® Transforming Powder Dressing
Altrazeal® Transforming Powder Dressing will be applied during the Baseline visit. It should be left in place for up to 30 days, and topped off (additional powder applied if needed) at each subsequent visit. Secondary dressing, including a contact layer over the Altrazeal® and a secondary dressing (like gauze or foam) may be applied over the contact layer.
Altrazeal® Transforming Powder Dressing
Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm
Interventions
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Altrazeal® Transforming Powder Dressing
Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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. -
18 Years
85 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
ULURU Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Saxe Johathan, MD
Role: PRINCIPAL_INVESTIGATOR
Altrazeal Life Sciences Inc
Locations
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San Diego VA
San Diego, California, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Northwestern Medicine
Chicago, Illinois, United States
Medstar Franklin Square Medical Center
Baltimore, Maryland, United States
Medstar Good Samaritan Hospital
Baltimore, Maryland, United States
Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic
Newark, New Jersey, United States
Northwell Health System/Zucker School of Medicine
Lake Success, New York, United States
NYU Langone Hospital-Long Island
Mineola, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion
Valhalla, New York, United States
University of Pittsburgh Medical Center (UPMC) Presbyterian
Pittsburgh, Pennsylvania, United States
VA North Texas Healthcare System
Dallas, Texas, United States
Michael E. DeBakey Houston VAMC
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline. Emily Haesler (ed.). EPUAP/NPIAP/PPPIA: 2019.
Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
Essex HN, Clark M, Sims J, Warriner A, Cullum N. Health-related quality of life in hospital inpatients with pressure ulceration: assessment using generic health-related quality of life measures. Wound Repair Regen. 2009 Nov-Dec;17(6):797-805. doi: 10.1111/j.1524-475X.2009.00544.x.
Sebba Tosta de Souza DM, Veiga DF, Santos ID, Abla LE, Juliano Y, Ferreira LM. Health-Related Quality of Life in Elderly Patients With Pressure Ulcers in Different Care Settings. J Wound Ostomy Continence Nurs. 2015 Jul-Aug;42(4):352-9. doi: 10.1097/WON.0000000000000142.
https://www.ahrq.gov/patient safety/settings/hospital/resource/pressureulcer/tool/pu1.html#:~:text=Cost%3A%20Press ure%20ulcers%20cost%20%249.1,related%20to%20pressure%20ulcers%20annually.
Related Links
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Altrazeal (Transforming Powder Dressing) product information
Other Identifiers
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U-C-TPD-2022-01
Identifier Type: -
Identifier Source: org_study_id
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