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

NCT05496296 | Recruiting FDA Device

• 1 other identifier: U-C-TPD-2022-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 14

Brief Summary

Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a "dressing, wound, hydrogel" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.

Conditions

Pressure Ulcers Stage II; Pressure Ulcers Stage III; Pressure Ulcer, Stage IV

Keywords

Wound care; Quality of life; Pain

Outcome Measures

Primary Outcomes (1)

• Number of wound dressing changes

  The number of primary dressing changes for each treatment group will be compared.

  12 weeks

Secondary Outcomes (4)

• Wound healing

  12 weeks

• Complications (problems) from treating the pressure wound

  12 weeks

• Pain in the wound and from dressing changes.

  12 weeks

• Wound Quality of Life

  12 weeks

Study Arms (2)

Standard of Care Dressing for Pressure Injury

ACTIVE COMPARATOR

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.

Device: Altrazeal® Transforming Powder Dressing

Altrazeal® Transforming Powder Dressing

ACTIVE COMPARATOR

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.

Device: Altrazeal® Transforming Powder Dressing

Interventions

Altrazeal® Transforming Powder Dressing DEVICE

Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm

Also known as: Standard of Care wound dressings (such as foam, hydrocolloid, collagen, etc)

Altrazeal® Transforming Powder Dressing; Standard of Care Dressing for Pressure Injury

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 85 years of age;
• Stage 2, 3, or 4 Pressure Injuries;
• Wound exudate is mild to moderate;
• No clinically active wound infection (clinical diagnosis);
• Able and willing to provide written (not proxy) informed consent;
• Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.

You may not qualify if:

• Known allergy or hypersensitivity to TPD or its components;
• Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
• Heavily exudative wounds;
• Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema \>0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;
• Poorly controlled diabetes with HgbA1C \>12 (as documented in the last 3 months);
• Body Mass Index (BMI) \>45 kg/m2;
• Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
• Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \<0.7 on the affected limb, if wound is located on the limb);
• Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
• Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;
• Wounds with necrosis unable to undergo prior definitive debridement;
• Fistulas;
• Active gangrene;
• Untreated HIV;
• Currently pregnant or lactating;

Sponsors & Collaborators

• ULURU Inc.: lead
• United States Department of Defense: collaborator

Study Sites (14)

San Diego VA

San Diego, California, 92161, United States

RECRUITING

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Northwestern Medicine

Chicago, Illinois, 60611, United States

ACTIVE NOT RECRUITING

Medstar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

RECRUITING

Medstar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

RECRUITING

Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic

Newark, New Jersey, 07103, United States

RECRUITING

Northwell Health System/Zucker School of Medicine

Lake Success, New York, 11042, United States

RECRUITING

NYU Langone Hospital-Long Island

Mineola, New York, 11501, United States

RECRUITING

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion

Valhalla, New York, 10595, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC) Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

VA North Texas Healthcare System

Dallas, Texas, 75243, United States

RECRUITING

Michael E. DeBakey Houston VAMC

Houston, Texas, 77030, United States

RECRUITING

Related Publications (5)

• European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline. Emily Haesler (ed.). EPUAP/NPIAP/PPPIA: 2019.

  BACKGROUND

• Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.

  PMID: 30664905 BACKGROUND

• Essex HN, Clark M, Sims J, Warriner A, Cullum N. Health-related quality of life in hospital inpatients with pressure ulceration: assessment using generic health-related quality of life measures. Wound Repair Regen. 2009 Nov-Dec;17(6):797-805. doi: 10.1111/j.1524-475X.2009.00544.x.

  PMID: 19903301 BACKGROUND

• Sebba Tosta de Souza DM, Veiga DF, Santos ID, Abla LE, Juliano Y, Ferreira LM. Health-Related Quality of Life in Elderly Patients With Pressure Ulcers in Different Care Settings. J Wound Ostomy Continence Nurs. 2015 Jul-Aug;42(4):352-9. doi: 10.1097/WON.0000000000000142.

  PMID: 26135820 BACKGROUND

• https://www.ahrq.gov/patient safety/settings/hospital/resource/pressureulcer/tool/pu1.html#:~:text=Cost%3A%20Press ure%20ulcers%20cost%20%249.1,related%20to%20pressure%20ulcers%20annually.

  BACKGROUND

Related Links

• Altrazeal (Transforming Powder Dressing) product information

MeSH Terms

Conditions

Pressure Ulcer; Pain

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Saxe Johathan, MD

  Altrazeal Life Sciences Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry Wallace

CONTACT

513 702 7536; kwallace@altrazeal.com

Susan St. John, MSN

CONTACT

sstjohn@altrazeal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Prospective, Controlled, Open-label, Parallel Group, Multicenter

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: April 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)