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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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 more

Trial 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

861 Previous Clinical Trials

226,894 Total Patients Enrolled

Saxe Johathan, MDPrincipal InvestigatorAltrazeal Life Sciences Inc

Media Library

Altrazeal® Transforming Powder Dressing (Hydrogel Dressing) Clinical Trial Eligibility Overview. Trial Name: NCT05496296 — N/A

Pressure Sores Research Study Groups: Altrazeal® Transforming Powder Dressing, Standard of Care Dressing for Pressure Injury

Pressure Sores Clinical Trial 2023: Altrazeal® Transforming Powder Dressing Highlights & Side Effects. Trial Name: NCT05496296 — N/A

Altrazeal® Transforming Powder Dressing (Hydrogel Dressing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496296 — N/A

Frequently Asked Questions

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

Are there any available slots for prospective volunteers in this experiment?

"As per clinicaltrials.gov, this trial is currently recruiting participants who fit the required criteria; the study was first posted on April 30th 2023 and last updated on June 27th 2023."

Answered by AI

How many geographic sites are administering this trial?

"This medical study is taking place at 5 different sites, with locations in the Bronx, Mineola and Pittsburgh as well as other cities. To reduce any logistical inconveniences for those who join the trial, it's best to select a nearby centre."

Answered by AI

How many individuals are currently enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical experiment, uploaded on April 30th 2023 and recently edited on June 27th 2023, is currently seeking participants. 300 individuals are required from 5 distinct sites."

Answered by AI

Who would be eligible to enlist in this medical experiment?

"This clinical trial is seeking 300 volunteers aged 18-85 with pressure injuries ranging from stage 2 to 4. Wound exudate should be mild to moderate and the patient must not present any active wound infection. Additionally, participants must display a sense of stability as indicated by an assessment of their medical history, vitals signs, physical examination and laboratory tests prior to enrollment. Ultimately they need to provide written consent in order for them to take part in this study."

Answered by AI

Is the age of consent for this clinical trial below 80 years old?

"To be eligible for this medical trial, potential participants must between 18 and 85 years of age. There are 56 studies specifically tailored to minors while 315 focus on seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries

2023. "Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05496296.