๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-16

Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing (NCT05424354)

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

๐ŸŸข Recruiting Phase4 โš™๏ธ Medical Device Protocol Sponsor: ULURU Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: University of California-Irvine โ€” Orange, California

Age range: 18 Years to 65 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (6 Sites)

  • University of California-Irvine โ€” Orange, California
  • MedStar Washington Hospital Center โ€” Washington D.C., District of Columbia
  • Jackson Memorial Hospital UM/JMH Burn Center โ€” Miami, Florida
  • University of Louisville Health โ€” Louisville, Kentucky
  • Westchester Medical Center โ€” Valhalla, New York
  • University of Texas SW (Parkland) โ€” Dallas, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (214) 905-5145

Email: vshah@uluruinc.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—