Transforming Powder Dressing for Pressure Sores

Recruiting at 14 trial locations

Overseen By Kerry Wallace

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ULURU Inc.

Must not be taking: Immunosuppressants, Biologics

Disqualifiers: Uncontrolled diabetes, High BMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new dressing called Altrazeal® Transforming Powder Dressing for treating pressure sores, which are painful skin wounds often affecting individuals who remain in one position for extended periods. Participants will either receive the usual care for pressure injuries or try the Altrazeal® dressing. The trial aims to determine if Altrazeal® heals these sores more effectively. Ideal participants have moderate to severe pressure injuries that are not infected and have mild to moderate fluid (exudate). This trial may suit those currently dealing with stage 2, 3, or 4 pressure sores and seeking new treatment options. As an unphased trial, it offers a unique opportunity for patients to explore innovative treatments for pressure sores.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving immunosuppression or biologics, or certain treatments like hyperbaric oxygen, you may not be eligible to participate.

What prior data suggests that this dressing is safe for treating pressure injuries?

A previous study found Altrazeal® Transforming Powder Dressing to be safe and easy to use. Research shows that this dressing often helps reduce pain for users. Observations from clinical settings suggest it is a safe choice for treating wounds. The FDA has approved Altrazeal® as a medical device for wound care, indicating it meets certain safety standards. Overall, evidence suggests that Altrazeal® is a safe option for managing pressure sores. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Altrazeal® Transforming Powder Dressing because it offers a novel approach to treating pressure sores. Unlike standard dressings like hydrocolloid or foam, which require frequent changes based on wound conditions, Altrazeal® can be left in place for up to 30 days. This powder transforms into a flexible, breathable film that conforms to the wound, potentially reducing the need for constant dressing changes and enhancing the healing environment. This innovative delivery method could simplify wound care and improve patient comfort and outcomes.

What evidence suggests that Altrazeal® Transforming Powder Dressing is effective for pressure injuries?

Research has shown that Altrazeal® Transforming Powder Dressing, which participants in this trial may receive, may help treat pressure injuries. In one study, all 21 patients with stage 2 to stage 4 pressure sores healed successfully and more quickly. The most severe wounds, stage 4, took about 87 days to heal. Additionally, a review of 19 studies found that patients experienced less pain when using this dressing. These findings suggest that Altrazeal® could effectively improve healing and comfort for pressure sores. ^{1 2 3 4 6}

Who Is on the Research Team?

Saxe Johathan, MD

Principal Investigator

Altrazeal Life Sciences Inc

Are You a Good Fit for This Trial?

This trial is for individuals with stage 2, 3, or 4 pressure injuries (bedsores) who can consent to treatment and have mild to moderate wound exudate without active infection. They must be clinically stable and able to attend up to 12 study visits over three months. Excluded are those with heavily draining wounds, certain diseases in the affected limb, recent immunosuppression therapy, concurrent treatments that affect outcomes, unstageable sores or Stage 1 injuries, severe diabetes or obesity, specific vascular issues in limbs with wounds, untreated HIV/AIDS patients.

Inclusion Criteria

Able and willing to provide written (not proxy) informed consent

Stage 2, 3, or 4 Pressure Injuries

Wound exudate is mild to moderate

Exclusion Criteria

Heavily exudative wounds

Venous stasis disease or lymphedema in 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline

Randomization occurs and the first treatment is applied

1 visit

1 visit (in-person)

Treatment

Participants receive wound evaluation, measurements, and treatment for 12 weeks

12 weeks

12 visits (in-person)

Follow-up

Participants complete a Subject Satisfaction Survey and are monitored for any final assessments

1 visit

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Altrazeal® Transforming Powder Dressing

Trial Overview

The trial compares standard care for bedsores recommended by the National Pressure Injury Advisory Panel against Altrazeal®, a hydrogel dressing that can stay on for up to a month. Participants will either receive standard care or Altrazeal® randomly and their progress will be monitored through outpatient visits or during hospitalization over a period of twelve weeks.

How Is the Trial Designed?

Group I: Altrazeal® Transforming Powder Dressing Active Control 1 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 Injury Active Control 1 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.

Who Is Running the Clinical Trial?

ULURU Inc.

Lead Sponsor

Trials

5

Recruited

600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The Exufiber dressing significantly improved the condition of peri-wound skin in patients with diabetic foot ulcers, with the number of patients having healthy skin increasing from 28.6% to 66.7% over 12 weeks.

There was a statistically significant reduction in wound area and volume, indicating effective management of exuding wounds, while the dressing was safe with no reported adverse events related to its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open, non-comparative, multi-centre post clinical study of the performance and safety of a gelling fibre wound dressing on diabetic foot ulcers. Chadwick, P., McCardle, J.[2016]

In a study involving 37 bedridden older patients, a newly developed dressing significantly reduced the incidence of persistent erythema compared to a control area, indicating its effectiveness in preventing skin damage (P = 0.007).

The dressing also improved skin hydration during application and maintained higher hydration levels after removal, while safely lowering skin pH without increasing the risk of pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new pressure ulcer preventive dressing containing ceramide 2 with low frictional outer layer. Nakagami, G., Sanada, H., Konya, C., et al.[2013]

Citations

1.

altrazeal.com

altrazeal.com/wp-content/uploads/2024/01/Evaluation-of-altrazeal-transforming-powder-dressing-on-stage-2-4-pressure-injuries.pdf

Evaluation-of-altrazeal-transforming-powder-dressing-on- ...

Methods: This case series used retrospective data from patients with stage 2–4 PUs that failed to heal after SoC therapies. Factors examined were: number of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11402518/

A systematic review on the use of transforming powder ...

A total of 19 studies (73%) discussed pain, each of which reported reduced pain with the use of transforming powder dressing. The evaluated studies collectively ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05496296

Comparison of Transforming Powder Dressing to NPIAP ...

This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1111/iwj.70046

A systematic review on the use of transforming powder ...

A total of 19 studies (73%) discussed pain, each of which reported reduced pain with the use of transforming powder dressing. The evaluated ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35576198/

Evaluation of Altrazeal transforming powder dressing on ...

Results: Each of the 21 patients treated with TPD experienced successful and expedited wound closure. Stage 4 PUs took an average of 87 days ...

6.

altrazeal.com

altrazeal.com/wp-content/uploads/2023/12/Transforming-Powder-Dressing-with-Extended-Wear-Time-Retrospective-Evaluation-in-Trauma-Injuries.pdf

Transforming-Powder-Dressing-with- ...

Clinical observations and outcomes indicate that Altrazeal presents a safe, effective and resource-efficient modality for the treatment of patients with ...