NCT05424354 Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
| NCT ID | NCT05424354 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | ULURU Inc. |
| Condition | Wounds and Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-26 |
| Primary Completion | 2026-06-30 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2022-05-26 with a primary completion date of 2026-06-30.
⚠ 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
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.
Eligibility Criteria
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
Contact & Investigator
Jonathan Saxe, MD
PRINCIPAL INVESTIGATOR
ULURU Inc.
Frequently Asked Questions
Who can join the NCT05424354 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Wounds and Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05424354 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05424354 currently recruiting?
Yes, NCT05424354 is actively recruiting participants. Contact the research team at vshah@uluruinc.com for enrollment information.
Where is the NCT05424354 trial being conducted?
This trial is being conducted at Orange, United States, Washington D.C., United States, Miami, United States, Louisville, United States and 2 additional locations.
Who is sponsoring the NCT05424354 clinical trial?
NCT05424354 is sponsored by ULURU Inc.. The principal investigator is Jonathan Saxe, MD at ULURU Inc.. The trial plans to enroll 60 participants.