Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing

Recruiting now · Phase 4

Conditions studied: Wounds and Injuries

In brief

This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.

Key facts

Study ID

NCT05424354

Run by

ULURU Inc.

People needed

60

Starts

2022-05-26

Expected to finish

2026-09-30

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
• Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
• Wounds must be partial thickness, involving up to 20% of the total body surface area.
• Burn injury should be less than 72 hours old
• Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
• Willing and able to provide written informed consent.

You may not qualify if…

• Known allergy to TPD or its components
• Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
• Infected wounds
• Presence of any full thickness (third degree) burns
• Electrical burns
• Heavily draining burns due to underlying chronic lymphedema or other conditions
• Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.
• History of poor wound healing and/or skin/immune system condition
• Deemed by clinician not to be suitable
• Unwilling or not able to provide consent or comply with protocol or required visits
• Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol
• Active alcohol or substance abuse

Where it is running

• University of California-Irvine — Orange, California, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Jackson Memorial Hospital UM/JMH Burn Center — Miami, Florida, United States (enrolling)
• University of Louisville Health — Louisville, Kentucky, United States (enrolling)
• Westchester Medical Center — Valhalla, New York, United States (enrolling)
• University of Texas SW (Parkland) — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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