Transforming Powder Dressing for Burns

Recruiting at 6 trial locations

Overseen By Susan St John, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: ULURU Inc.

Disqualifiers: Pregnancy, Infected wounds, Full thickness burns, Electrical burns, Alcohol/substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 28 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new burn treatment called Altrazeal(R) Transforming Powder Dressing (TPD) to evaluate its effectiveness compared to standard burn dressings. It focuses on individuals with fresh partial thickness burns covering less than 20% of their body. Participants will be randomly assigned to receive either the new TPD treatment or the usual care and will be monitored for up to 28 days. Ideal candidates are those hospitalized with a burn wound less than 72 hours old. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for these treatments?

Research has shown that Altrazeal Transforming Powder Dressing (TPD) is generally safe for treating wounds. Patients typically tolerate it well, with treatment lasting about 33 days and dressings changed every six days. A systematic review suggests that Altrazeal is safe and can aid in healing and pain relief. Overall, the evidence supports TPD as a reliable choice for wound care with minimal risk. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care treatments for acute partial thickness burns, such as silver sulfadiazine creams and hydrocolloid dressings, Altrazeal(R) Transforming Powder Dressing (TPD) offers a unique approach through its transforming powder mechanism. Researchers are excited about TPD because it forms a gel-like layer when it comes into contact with wound moisture, creating a breathable barrier that helps maintain a moist environment conducive to healing. This innovative delivery method can potentially accelerate the healing process and reduce dressing changes, offering a more comfortable and convenient option for patients.

What evidence suggests that Altrazeal(R) Transforming Powder Dressing is effective for partial thickness burns?

This trial will compare Altrazeal Transforming Powder Dressing (TPD) with the Standard of Care burn dressing. Research has shown that TPD can accelerate the healing of burn wounds. Studies have found that TPD supports new skin growth over burns and helps reduce pain. Clinical observations indicate that Altrazeal provides a safe and efficient wound treatment. Patients using TPD have experienced positive results, making it a promising option for treating certain types of burns. ^{1 2 3 5 6}

Who Is on the Research Team?

Jonathan Saxe, MD

Principal Investigator

ULURU Inc.

Are You a Good Fit for This Trial?

Adults aged 18-65 with acute partial thickness burns covering less than 20% of their body, hospitalized or stable enough for outpatient treatment. Participants must have sustained the burn within the last 36 hours and be able to attend follow-up visits and give informed consent.

Inclusion Criteria

I am hospitalized for burn care but can continue treatment as an outpatient when stable.

My burn injury occurred within the last 36 hours.

Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either Transforming Powder Dressing (TPD) or Standard of Care (SOC) dressing for burn wounds

28 days

7 visits (in-person) on Days 0, 3, 7, 10, 14, 21, and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Altrazeal(R) Transforming Powder Dressing
• Standard of Care burn dressing

Trial Overview The trial compares Altrazeal(R) Transforming Powder Dressing (TPD) with Standard of Care (SOC) dressing on patients with partial thickness burns. It's a randomized study where participants are equally divided into two groups to receive either TPD or SOC for up to 28 days.

How Is the Trial Designed?

Group I: Transforming Powder Dressing Experimental Treatment 1 Intervention

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).

Group II: Standard of Care Dressing Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

ULURU Inc.

Lead Sponsor

Trials

5

Recruited

600+

Navy Advanced Medical Development (NAMD) Command

Collaborator

Trials

1

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11402518/

A systematic review on the use of transforming powder ... The evaluated studies collectively suggest that transforming powder dressing offers a promising re‐epithelialization rate and analgesic effect across various ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/iwj.70046

A systematic review on the use of transforming powder ... The evaluated studies collectively suggest that transforming powder dressing offers a promising re-epithelialization rate and analgesic effect ...

3. altrazeal.com altrazeal.com/wp-content/uploads/2023/12/Transforming-Powder-Dressing-with-Extended-Wear-Time-Retrospective-Evaluation-in-Trauma-Injuries.pdf

Transforming-Powder-Dressing-with- ... Clinical observations and outcomes indicate that Altrazeal presents a safe, effective and resource-efficient modality for the treatment of patients with ...

4. altrazeal.com altrazeal.com/wp-content/uploads/2024/01/Evaluation-of-altrazeal-transforming-powder-dressing-on-stage-2-4-pressure-injuries.pdf

Evaluation-of-altrazeal-transforming-powder-dressing-on- ... While data were assessed for all patients, we focused on the six particular cases that most clearly illustrated the effect of TPD on wound healing. Results: ...

5. jcimcr.org jcimcr.org/pdfs/JCIMCR-v5-3075.pdf

The effects of photobiomodulation therapy plus ... When used for diabetic foot, this therapy has been shown to be effective [19] and burn patients' skin graft do- nor sites. Using this dressing ...

6. altrazeal.com altrazeal.com/wp-content/uploads/2023/12/4.-2023-MHSRS-Oral-Presentation-Burns-1.pdf

TREATMENT OF PARTIAL THICKNESS BURN WOUNDS ... Data on file at Altrazeal Life Sciences Inc. Page 18. COOKING GREASE HAND ... An easy-to-use powder dressing that improved wound healing and enhanced ...