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

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.

Study Overview

• Status: Recruiting
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Altrazeal (R) Transforming Powder Dressing; Other: Standard of Care burn dressing

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vai Shah; Phone Number: 2149055145; Email: vshah@uluruinc.com
• Study Contact Backup: Name: Susan St John, MSN; Phone Number: 4123035379; Email: sstjohn@uluru.com

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • University of California-Irvine
      • Contact: Lizette Spears; Phone Number: 714-456-5840; Email: lspiers@hs.uci.edu
      • Contact: Taina Aruju; Phone Number: 714-456-5840; Email: taraujo@hs.uci.edu
      • Principal Investigator: Victor Joe, MD
      • Sub-Investigator: Theresa Chin, MD
      • Sub-Investigator: Kimberly Burton, PA
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
      • Principal Investigator: Jeffrey Shupp, MD
      • Contact: Mary (Abby) Bellon; Phone Number: 202 877 3519; Email: Mary.A.Bellon@medstar.net
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Jackson Memorial Hospital UM/JMH Burn Center
      • Principal Investigator: Carl I Schulman, MD
      • Contact: Lisa Otero, BA; Phone Number: 305-585-1348; Email: lao77@med.miami.edu
      • Sub-Investigator: Joyce I Kaufman, MD
      • Sub-Investigator: Louis R Pizano, MD
      • Sub-Investigator: Shevonne S Satahoo, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Health
      • Contact: Madison Rutledge; Phone Number: (502) 629-3327; Email: madison.rutledge@louisville.edu
      • Contact: Michelle Broers; Email: michelle.broers@uoflhealth.org
      • Principal Investigator: Matthew Bozeman, MD
  • New York
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Westchester Medical Center
      • Contact: Daniela Santamaria-Vargas, MSc; Phone Number: 9144931528; Email: Daniela.Santamaria-Vargas@wmchealth.org
      • Contact: Falyn Katzman, MPH; Email: Falyn.Katzman@wmchealth.org
      • Principal Investigator: Joseph Turkowski, MD
      • Sub-Investigator: Maryana Koshyk, PA-C
      • Sub-Investigator: Rachelle Lodescar, MD
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • University of Texas SW (Parkland)
      • Principal Investigator: Caroline Park, MD
      • Contact: Scarlett Dwyer; Phone Number: 214 645-0445; Email: Scarlett.Dwyer@utsouthwestern.edu
      • Sub-Investigator: Chiaka Akarichi, MD
      • Sub-Investigator: Rebecca Coffey, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transforming Powder Dressing; 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).	Device: Altrazeal (R) Transforming Powder Dressing; 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.
Active Comparator: Standard of Care Dressing; 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).	Other: Standard of Care burn dressing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days (or sooner if the wound heals prior to 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Wounds will measured at each study visit to determine surface area healing.	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.	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.	End of Study

Collaborators and Investigators

• Sponsor: ULURU Inc.
• Collaborators: Navy Advanced Medical Development (NAMD) Command
• Investigators: Principal Investigator: Jonathan Saxe, MD, ULURU Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: burn
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: U-C-TPD-2021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes