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Wound Dressing

Altrazeal (R) Transforming Powder Dressing for Wounds and Injuries

Phase 4
Waitlist Available
Led By Jonathan Saxe, MD
Research Sponsored by ULURU Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days (or sooner if the wound heals prior to 28 days)
Awards & highlights

Study Summary

This trial is testing a new burn dressing to see if it's better than the current standard of care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days (or sooner if the wound heals prior to 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days (or sooner if the wound heals prior to 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain from the Burn Wound
Secondary outcome measures
Safety of the Interventions (TPD and SOC)
Subject satisfaction
Wound healing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transforming Powder DressingExperimental Treatment1 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 DressingActive Control1 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).

Find a Location

Who is running the clinical trial?

Navy Advanced Medical Development (NAMD) CommandUNKNOWN
ULURU Inc.Lead Sponsor
4 Previous Clinical Trials
543 Total Patients Enrolled
Jonathan Saxe, MDPrincipal InvestigatorULURU Inc.
1 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for persons wishing to join this medical experiment?

"The clinicaltrial.gov website confirms that this trial is not actively recruiting patients, despite its original posting on May 26th 2022 and most recent update on June 14th 2022. However, there are 738 other trials still open for enrolment at present."

Answered by AI

Does this experiment involve any individuals of advanced age?

"The age range for participants of this clinical trial is 18 to 65. Those outside of the specified boundaries can look into 122 trials tailored towards minors or 590 studies dedicated to senior citizens."

Answered by AI

Does Altrazeal (R) Transforming Powder Dressing pose any risks of harm to users?

"Altrazeal (R) Transforming Powder Dressing has been granted approval, thus the safety rating for this product is a 3 on our team's scale."

Answered by AI

Are there still opportunities to partake in this medical investigation?

"In order to be considered eligible, the prospective patient should have wounds and fall between ages 18 and 65. Currently, approximately 60 individuals are being recruited for this clinical experiment."

Answered by AI
~21 spots leftby Mar 2025