Wounds and InjuriesPhase 4NCT05424354
Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
A Phase 4 study testing Altrazeal (R) Transforming Powder Dressing in people with Wounds and Injuries, run by ULURU Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Altrazeal (R) Transforming Powder Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 May 2022to 30 Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Texas SW (Parkland)
Dallas, Texas, 75235
Scarlett Dwyer, 214 645-0445, Scarlett.Dwyer@utsouthwestern.edu
Caroline Park, MD
- Recruiting
University of Louisville Health
Louisville, Kentucky, 40202
Madison Rutledge, (502) 629-3327, madison.rutledge@louisville.edu
Michelle Broers, michelle.broers@uoflhealth.org
- Recruiting
Jackson Memorial Hospital UM/JMH Burn Center
Miami, Florida, 33136
Lisa Otero, BA, 305-585-1348, lao77@med.miami.edu
Carl I Schulman, MD
- Recruiting
University of California-Irvine
Orange, California, 92868
Lizette Spears, 714-456-5840, lspiers@hs.uci.edu
Taina Aruju, 714-456-5840, taraujo@hs.uci.edu
- Recruiting
Westchester Medical Center
Valhalla, New York, 10595
Daniela Santamaria-Vargas, MSc, 9144931528, Daniela.Santamaria-Vargas@wmchealth.org
Falyn Katzman, MPH, falyn.katzman@wmchealth.org
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Mary (Abby) Bellon, 202 877 3519, Mary.A.Bellon@medstar.net
Jeffrey Shupp, MD
About this study
Official title: Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds
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.
Read the detailed description
This post-marketing 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 for burn wounds. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, comprising 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 during hospitalization and then upon discharge from the hospital for up to 28 days after enrollment into the study. At each of the 8 study visits, the burn wound will be evaluated, photographed and measured. The wound will be cleaned and debrided, if needed, per usual standard burn care. A wound dressing will be applied using TPD or a typical SOC dressing. Wound healing and wound pain will be monitored at each visit, and the results of the two groups (TPD and SOC) will be compared to each other. A survey evaluating the satisfaction with the dressing received will be given at the end of the study, or when the wound heals, whichever comes first.
- Conditions
- Wounds and Injuries
- Being tested
- Altrazeal (R) Transforming Powder Dressing, Standard of Care burn dressing
- Keywords
- burn
- Medical subject headings
- Wounds and Injuries, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altrazeal (R) Transforming Powder DressingDevice
After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD.
Standard of Care burn dressingOther
After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with the institution's standard of care burn dressing.
| Study group | Role | What they receive |
|---|---|---|
| Transforming Powder Dressing | Experimental | Half of the subjects will be randomized to Transforming Powder Dressing (TPD) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. TPD will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing). Receives: Device: Altrazeal (R) Transforming Powder Dressing |
| Standard of Care Dressing | Active comparator | Half of the subjects will be randomized to Standard of Care (SOC) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. The standard of care burn dressing will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing). Receives: Other: Standard of Care burn dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain from the Burn Wound
Subjects will complete a visual analogue scale (VAS) to rate their pain prior to, during and after dressing changes. The scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain possible.
Measured: 28 days (or sooner if the wound heals prior to 28 days)
Secondary outcomes (3)
Wound healing
Wounds will measured at each study visit to determine surface area healing.
Measured: 28 days (or sooner if the wound heals prior to 28 days)
Safety of the Interventions (TPD and SOC)
Complications such as infection, and other adverse events that develop will be documented, evaluated for severity, and compared between intervention groups.
Measured: 28 days (or sooner if the wound heals prior to 28 days)
Subject satisfaction
Subjects will be asked to complete a subject satisfaction survey, which consists of 8 multiple choice questions regarding their wound dressing.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start26 May 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Prospective, Multi-Center, Open Label, Comparison, Human, Interventional
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ULURU Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Navy Advanced Medical Development (NAMD) Command
- Responsible party
- Sponsor
- Investigators
- Jonathan Saxe, MD, Principal investigator, ULURU Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424354
- Sponsor's protocol ID
- U-C-TPD-2021-02
- Status last verified
- Nov 2025
- First submitted
- 10 Jun 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds
- ClinicalTrials.gov ID
- NCT05424354
- Acronym / sponsor ID
- U-C-TPD-2021-02
- Conditions
- Wounds and Injuries
- Keywords
- burn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ULURU Inc.Industry (pharma, biotech, devices)
- Collaborators
- Navy Advanced Medical Development (NAMD) Command
- Study start
- 26 May 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This post-marketing 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 for burn wounds. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, comprising 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 during hospitalization and then upon discharge from the hospital for up to 28 days after enrollment into the study. At each of the 8 study visits, the burn wound will be evaluated, photographed and measured. The wound will be cleaned and debrided, if needed, per usual standard burn care. A wound dressing will be applied using TPD or a typical SOC dressing. Wound healing and wound pain will be monitored at each visit, and the results of the two groups (TPD and SOC) will be compared to each other. A survey evaluating the satisfaction with the dressing received will be given at the end of the study, or when the wound heals, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Prospective, Multi-Center, Open Label, Comparison, Human, Interventional
| Arm | Type | Receives |
|---|---|---|
| Transforming Powder Dressing | Experimental | Device: Altrazeal (R) Transforming Powder DressingHalf of the subjects will be randomized to Transforming Powder Dressing (TPD) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. TPD will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing). |
| Standard of Care Dressing | Active comparator | Other: Standard of Care burn dressingHalf of the subjects will be randomized to Standard of Care (SOC) to treat the burn wound(s). Subjects will be evaluated on Treatment Day 0, 3, 7, 10, 14, 21, and 28 (or sooner if the wound heals prior to end of study visit on Day 28). On each study visit, wound care will be performed. The standard of care burn dressing will be applied directly on the burn wound, followed by another dressing (often called a secondary dressing). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- Known allergy to TPD or its components
- Infected wounds
- Presence of any full thickness (third degree) burns
- Electrical burns
- Heavily draining burns due to underlying chronic lymphedema or other conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altrazeal (R) Transforming Powder DressingAfter informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD. | Device | Transforming Powder Dressing |
| Standard of Care burn dressingAfter informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with the institution's standard of care burn dressing. | Other | Standard of Care Dressing |
Primary outcome
Pain from the Burn Wound
Time frame: 28 days (or sooner if the wound heals prior to 28 days)
Subjects will complete a visual analogue scale (VAS) to rate their pain prior to, during and after dressing changes. The scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain possible.
3 secondary outcomes
Wound healing
Time frame: 28 days (or sooner if the wound heals prior to 28 days)
Safety of the Interventions (TPD and SOC)
Time frame: 28 days (or sooner if the wound heals prior to 28 days)
Subject satisfaction
Time frame: End of Study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Saxe, MD principal investigator
ULURU Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Altrazeal (R) Transforming Powder Dressing in people with Wounds and Injuries, run by ULURU Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vai Shah (2149055145, vshah@uluruinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain from the Burn Wound (time frame: 28 days (or sooner if the wound heals prior to 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.