NCT05496296 Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
| NCT ID | NCT05496296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ULURU Inc. |
| Condition | Pressure Ulcers Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-04-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-04-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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. -
Contact & Investigator
Saxe Johathan, MD
PRINCIPAL INVESTIGATOR
Altrazeal Life Sciences Inc
Frequently Asked Questions
Who can join the NCT05496296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Pressure Ulcers Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05496296 currently recruiting?
Yes, NCT05496296 is actively recruiting participants. Contact the research team at kwallace@altrazeal.com for enrollment information.
Where is the NCT05496296 trial being conducted?
This trial is being conducted at San Diego, United States, Washington D.C., United States, Washington D.C., United States, Chicago, United States and 10 additional locations.
Who is sponsoring the NCT05496296 clinical trial?
NCT05496296 is sponsored by ULURU Inc.. The principal investigator is Saxe Johathan, MD at Altrazeal Life Sciences Inc. The trial plans to enroll 300 participants.