Pressure Ulcers Stage IINCT05496296
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
A study testing Altrazeal® Transforming Powder Dressing in people with Pressure Ulcers Stage II and Pressure Ulcers Stage III, run by ULURU Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers Stage II, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
- What is being tested?
- Altrazeal® Transforming Powder Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 14 sitesUnited States
- Study dates
- 30 Apr 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 25Show fewer
- 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. -
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Susan St. John, MSN contact
14 sites in 1 country
United States14 sites, 13 recruiting
- Recruiting
Medstar Franklin Square Medical Center
Baltimore, Maryland, 21237
Paul Carroll, DPM, (443) 777-7000, paul.j.carroll@medstar.net
Sariat Ibrahim, (443) 777-7000, Sariat.Ibrahim@medstar.net
- Recruiting
Medstar Good Samaritan Hospital
Baltimore, Maryland, 21239
Lumanti Manandhar, (443) 444-8000, lumanti.Manandhar@medstar.net
Mia Hamm, (443) 444-8000, Mia.A.Hamm@Medstar.net
- Active, not recruiting
Northwestern Medicine
Chicago, Illinois, 60611
- Recruiting
VA North Texas Healthcare System
Dallas, Texas, 75243
David Truong, DPM, 214-857-2602, David.Truong1@va.gov
Morgan Williams, 214-857-2602, Morgan.Williams5@va.gov
- Recruiting
Michael E. DeBakey Houston VAMC
Houston, Texas, 77030
Aimee Garcia, MD, 512-387-1876, Aimee.Garcia@va.gov
Felipe Salinas Martinez, 512-387-1876, Felipe.SalinasMartinez@va.gov
- Recruiting
Northwell Health System/Zucker School of Medicine
Lake Success, New York, 11042
Sally Kaplan, RN, 516-233-3781, skaplan2@northwell.edu
Farisha Baksh, 516-233-3781, fbaksh@northwell.edu
- Recruiting
NYU Langone Hospital-Long Island
Mineola, New York, 11501
Scott Gorenstein, MD, 516-663-8498, Scott.gorenstein@nyulangone.org
Monica Benitez, 516-663-8498, Monica.Benitez@nyulangone.org
- Recruiting
Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic
Newark, New Jersey, 07103
Mark Granick, MD, 973-972-1129, mgranickmd@njms.rutgers.edu
Saharsh Patel, ssp186@gsbs.rutgers.edu
- Recruiting
University of Pittsburgh Medical Center (UPMC) Presbyterian
Pittsburgh, Pennsylvania, 15213
Cecilia Zamarripa, PhD, RN, CWON, 412-647-7728, zamarripaca@upmc.edu
Bradley Good, 412-647-7728, goodb@upmc.edu
- Recruiting
San Diego VA
San Diego, California, 92161
Henry York, MD, 858-552-8585, Henry.York@va.gov
Emily Sears, 858-552-8585, esears@vmrf.org
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Galea Marinella, MD, 718-584-9000 ext. 5431, Marinella.Galea@va.gov
Katherine Bolanos Roldan, RN, 718-584-9000 ext. 5431, Katherine.BolanosRoldan@va.gov
- Recruiting
Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion
Valhalla, New York, 10595
Carlo Gwardschaladse, PA, 914-493-3047, Carlo.Gwardschaladse@wmchelath.org
Falyn Katzman, MPH, Falyn.Katzman@wmchealth.org
- Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Deanna Curbeam, 202 444 8751, Deanna.Curbeam@medstar.net
Kenneth Fan, MD
- Recruiting
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Suzanne L Groah, MD, (202) 877-1000, Suzanne.L.Groah@medstar.net
Ana Valeria Aguirreguemez, MD, (202) 877-1000, anavaleria.aguirreguemez@medstar.net
About this study
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
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.
Read the 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.
- Being tested
- Altrazeal® Transforming Powder Dressing
- Keywords
- Wound care, Quality of life, Pain
- Medical subject headings
- Pressure Ulcer, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altrazeal® Transforming Powder DressingDevice
Also called Standard of Care wound dressings (such as foam, hydrocolloid, collagen, etc)
Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Altrazeal® Transforming Powder Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of wound dressing changes
The number of primary dressing changes for each treatment group will be compared.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start30 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pressure Ulcers Stage IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, Prospective, Controlled, Open-label, Parallel Group, Multicenter
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ULURU Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Saxe Johathan, MD, Principal investigator, Altrazeal Life Sciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496296
- Sponsor's protocol ID
- U-C-TPD-2022-01
- Status last verified
- Nov 2025
- First submitted
- 8 Aug 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
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.
PubMed 30664905Essex 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.
PubMed 19903301Sebba 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.
PubMed 26135820https://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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05496296
- Acronym / sponsor ID
- U-C-TPD-2022-01
- Keywords
- Wound care, Quality of life, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ULURU Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Prospective, Controlled, Open-label, Parallel Group, Multicenter
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Dressing for Pressure Injury | Active comparator | Device: Altrazeal® Transforming Powder DressingStandard 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 | Active comparator | Device: Altrazeal® Transforming Powder DressingAltrazeal® 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (25 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altrazeal® Transforming Powder DressingAlso: Standard of Care wound dressings (such as foam, hydrocolloid, collagen, etc)Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm | Device | Altrazeal® Transforming Powder Dressing, Standard of Care Dressing for Pressure Injury |
Primary outcome
Number of wound dressing changes
Time frame: 12 weeks
The number of primary dressing changes for each treatment group will be compared.
4 secondary outcomes
Wound healing
Time frame: 12 weeks
Complications (problems) from treating the pressure wound
Time frame: 12 weeks
Pain in the wound and from dressing changes.
Time frame: 12 weeks
Wound Quality of Life
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- BackgroundEuropean 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: PubMed 30664905Mervis 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.
- Background: PubMed 19903301Essex 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.
- Background: PubMed 26135820Sebba 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.
- Backgroundhttps://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.
- Altrazeal (Transforming Powder Dressing) product informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan St. John, MSN contact
Saxe Johathan, MD principal investigator
Altrazeal Life Sciences Inc
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altrazeal® Transforming Powder Dressing in people with Pressure Ulcers Stage II and Pressure Ulcers Stage III, run by ULURU Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerry Wallace (513 702 7536, kwallace@altrazeal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of wound dressing changes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05496296, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.