NCT05424354 · ULURU Inc.
Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
What this study is about
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 the usual treatment (SOC) dressing.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Orange, California
- Washington D.C., District of Columbia
- Miami, Florida
- Louisville, Kentucky
- Valhalla, New York
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations