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Hydrogel Dressing
Transforming Powder Dressing for Pressure Sores
N/A
Recruiting
Led By Saxe Johathan, MD
Research Sponsored by ULURU Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will compare standard of care to Altrazeal® in treating pressure ulcers (2.5 mil in US). Subjects can be hospitalized or outpatient. Half will get standard of care, half Altrazeal®. 12 visits over 12 weeks.
Eligible Conditions
- Pressure Sores
- Pressure Sore
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of wound dressing changes
Secondary outcome measures
Complications (problems) from treating the pressure wound
Pain in the wound and from dressing changes.
Wound Quality of Life
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Altrazeal® Transforming Powder DressingActive Control1 Intervention
Altrazeal® Transforming Powder Dressing will be applied during the Baseline visit. It should be left in place for up to 30 days, and topped off (additional powder applied if needed) at each subsequent visit. Secondary dressing, including a contact layer over the Altrazeal® and a secondary dressing (like gauze or foam) may be applied over the contact layer.
Group II: Standard of Care Dressing for Pressure InjuryActive Control1 Intervention
Standard wound dressings recommended by the National Pressure Injury Advisory Panel (NPIAP), according to the wound stage, will be utilized to treat pressure injuries. These include hydrocolloid, hydrogel, polymeric membranes, foam, collagen dressings, and negative pressure wound therapy. Dressings will be changed according to wound conditions, and type of dressing selected.
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Who is running the clinical trial?
ULURU Inc.Lead Sponsor
4 Previous Clinical Trials
303 Total Patients Enrolled
United States Department of DefenseFED
867 Previous Clinical Trials
327,062 Total Patients Enrolled
Saxe Johathan, MDPrincipal InvestigatorAltrazeal Life Sciences Inc
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Altrazeal® Transforming Powder Dressing
- Group 2: Standard of Care Dressing for Pressure Injury
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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