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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Altrazeal® Transforming Powder Dressing
Sponsored by
ULURU Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcers Stage II focused on measuring Wound care, Quality of life, Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18 to 85 years of age;
  2. Stage 2, 3, or 4 Pressure Injuries;
  3. Wound exudate is mild to moderate;
  4. No clinically active wound infection (clinical diagnosis);
  5. Able and willing to provide written (not proxy) informed consent;
  6. Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.

Exclusion Criteria:

  1. Known allergy or hypersensitivity to TPD or its components;
  2. Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
  3. Heavily exudative wounds;
  4. 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;
  5. Poorly controlled diabetes with HgbA1C >12 (as documented in the last 3 months);
  6. Body Mass Index (BMI) >45 kg/m2;
  7. Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
  8. Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) <0.7 on the affected limb, if wound is located on the limb);
  9. Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
  10. 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;
  11. Wounds with necrosis unable to undergo prior definitive debridement;
  12. Fistulas;
  13. Active gangrene;
  14. Untreated HIV;
  15. Currently pregnant or lactating;
  16. Impending organ transplant;
  17. Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
  18. Unwilling or unable to comply with offloading recommendations;
  19. If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:

    1. Unable to keep research appointments;
    2. Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);
    3. Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;
    4. Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;
    5. Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;
    6. Not suitable for study participation. -

Sites / Locations

  • Northwestern MedicineRecruiting
  • James J. Peters VA Medical CenterRecruiting
  • NYU Langone Hospital-Long IslandRecruiting
  • University of Pittsburgh Medical Center (UPMC) PresbyterianRecruiting
  • VA North Texas Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard of Care Dressing for Pressure Injury

Altrazeal® Transforming Powder Dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Wound healing
Wound healing will be measured by using a ruler each week to report length and width of the wound. Percentage of wound area reduction will be calculated for each treatment group and compared.
Complications (problems) from treating the pressure wound
Subjects will be asked to report, will be questioned and observed (by the researchers) each study visit for any complications, problems or adverse events related to the study wound that they experience, such as maceration around the wound from the drainage, moisture, or dressing. Complications and adverse events will be compared during the course of the study
Pain in the wound and from dressing changes.
Subjects with sensation in the area of the wound will be asked to complete a validated visual analogue scale. This is a simple validated test asking the subject to rate their pain on a 0-10 point level, where 10 is the worst and 0 is no pain. Mean and median pain scores will be compared for each treatment group during the course of the study
Wound Quality of Life
Mean and median changes in validated Wound Quality of Life scores will be measured between groups during the course of the study

Full Information

First Posted
August 8, 2022
Last Updated
June 27, 2023
Sponsor
ULURU Inc.
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05496296
Brief Title
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Official Title
Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ULURU Inc.
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 with redness to full thickness wounds with deep tissue loss and exposed bone. This study will focus on patients with stage 2, stage 3 and stage 4 pressure injury wounds. It will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® Transforming Powder Dressing (TPD). 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. Altrazeal® is a powder dressing that conforms to the wound, covering and protecting it, shielding the wound from bacteria. Altrazeal® is used in conjunction with a secondary dressing when needed. The primary aim of the study is to evaluate whether dressing changes can be reduced during treatment of pressure injuries. The study will also compare wound healing between the group receiving Altrazeal® and the group receiving standard of care dressings, as well as complications, pain, quality of life, and overall costs between the two groups. Subjects will be randomized into 2 groups, standard of care and Altrazeal®. Half of the subjects will receive current standard of care treatment, and the other half will receive treatment with Altrazeal®. This is an open-label study, meaning that both the subject and the treatment provider will know what study group the subject has been randomized to. The first visit will be the screening visit to ensure patients meet eligibility criteria. Patients can be either an outpatient or hospitalized. Written informed consent will be obtained during this visit. A wound evaluation will be performed, and laboratory work ordered, if not done recently. Once identified as meeting study criteria, the next visit is Baseline Visit, where randomization will occur and the first treatment will take place. Participants will be evaluated for 12 additional consecutive weeks, receiving wound evaluation, measurements, and getting treatment for the wound. A pain evaluation, quality of life survey related to having a wound, questionnaire regarding additional wound care performed between study visits. Participants will also answer questions regarding how much offloading devices or maneuvers were utilized, medications taken, and if any complications developed related to their wound care. If the wound is healed prior to 12 weeks, the study will end when the wound is healed. Otherwise, the study will go on for 12 consecutive weeks. At the end of the study, the participant will be asked to complete a Subject Satisfaction Survey, answering questions regarding how the wound dressing worked for them. The surveys should take 5-10 minutes to complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers Stage II, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
Keywords
Wound care, Quality of life, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomized, Prospective, Controlled, Open-label, Parallel Group, Multicenter
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Dressing for Pressure Injury
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Altrazeal® Transforming Powder Dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Altrazeal® Transforming Powder Dressing
Other Intervention Name(s)
Standard of Care wound dressings (such as foam, hydrocolloid, collagen, etc)
Intervention Description
Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm
Primary Outcome Measure Information:
Title
Number of wound dressing changes
Description
The number of primary dressing changes for each treatment group will be compared.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Wound healing
Description
Wound healing will be measured by using a ruler each week to report length and width of the wound. Percentage of wound area reduction will be calculated for each treatment group and compared.
Time Frame
12 weeks
Title
Complications (problems) from treating the pressure wound
Description
Subjects will be asked to report, will be questioned and observed (by the researchers) each study visit for any complications, problems or adverse events related to the study wound that they experience, such as maceration around the wound from the drainage, moisture, or dressing. Complications and adverse events will be compared during the course of the study
Time Frame
12 weeks
Title
Pain in the wound and from dressing changes.
Description
Subjects with sensation in the area of the wound will be asked to complete a validated visual analogue scale. This is a simple validated test asking the subject to rate their pain on a 0-10 point level, where 10 is the worst and 0 is no pain. Mean and median pain scores will be compared for each treatment group during the course of the study
Time Frame
12 weeks
Title
Wound Quality of Life
Description
Mean and median changes in validated Wound Quality of Life scores will be measured between groups during the course of the study
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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; Impending organ transplant; Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients; Unwilling or unable to comply with offloading recommendations; If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because: Unable to keep research appointments; Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound); Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes; Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules; Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study; Not suitable for study participation. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jim Westerkamp
Phone
(214) 905-5145
Email
jwesterkamp@uluruinc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan St. John, MSN
Phone
(214) 905-5145
Email
sstjohn@uluruinc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saxe Johathan, MD
Organizational Affiliation
Altrazeal Life Sciences Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Galiano, MD
Phone
312-695-6022
Email
mailto:Robert.Galiano@nm.org
First Name & Middle Initial & Last Name & Degree
Kristin Huffman
Phone
3120926-7037
Email
mailto:kristin.huffman1@nm.org
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galea Marinella, MD
Phone
718-584-9000
Ext
5431
Email
Marinella.Galea@va.gov
First Name & Middle Initial & Last Name & Degree
Katherine Bolanos Roldan, RN
Phone
718-584-9000
Ext
5431
Email
Katherine.BolanosRoldan@va.gov
Facility Name
NYU Langone Hospital-Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Gorenstein, MD
Phone
516-663-8498
Email
mailto:Scott.gorenstein@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Sofia Cataliotti
Phone
516-663-8498
Email
mailto:Sofia.Cataliotti@nyulangone.org
Facility Name
University of Pittsburgh Medical Center (UPMC) Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Zamarripa, PhD, RN, CWON
Phone
412-647-7728
Email
zamarripaca@upmc.edu
First Name & Middle Initial & Last Name & Degree
Alex Craig
Phone
412-647-7728
Email
craiga11@upmc.edu
First Name & Middle Initial & Last Name & Degree
CeCe Zamarripa, PhD
Facility Name
VA North Texas Healthcare System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Truong, DPM
Phone
214-857-2602
Email
mailto:David.Truong1@va.gov
First Name & Middle Initial & Last Name & Degree
Cassie Lusk
Phone
214-857-2602
Email
Cassie.Lusk@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
30664905
Citation
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.
Results Reference
background
PubMed Identifier
19903301
Citation
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.
Results Reference
background
PubMed Identifier
26135820
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
http://www.Altrazeal.info
Description
Altrazeal (Transforming Powder Dressing) product information

Learn more about this trial

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

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