Transforming Powder Dressing for Pressure Sores

Recruiting at 4 trial locations

Overseen By Susan St. John, MSN

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

Trial Summary

What is the purpose of this trial?

This trial will evaluate the effectiveness of Altrazeal® for patients with severe pressure ulcers. Altrazeal® is a powder that forms a protective cover over wounds, helping them heal. The study aims to see if Altrazeal® can reduce dressing changes and improve healing. Altrazeal® offers a promising new form of wound treatment.

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 data supports the effectiveness of the treatment Altrazeal® Transforming Powder Dressing for pressure sores?

Research shows that a transforming powder dressing helped heal lower leg surgical wounds and large surgery wounds quickly and effectively, suggesting it may also be beneficial for pressure sores. ^{1 2 3 4 5}

Is the Transforming Powder Dressing safe for use in humans?

In a study involving two older patients with lower leg wounds, the Transforming Powder Dressing was used without any reported safety issues, and the wounds healed completely within four weeks. ^{1 3 6 7 8}

How is the treatment Altrazeal® Transforming Powder Dressing unique for pressure sores?

Altrazeal® Transforming Powder Dressing is unique because it transforms into a shape-retentive matrix when it gets wet, creating an optimal moist environment for wound healing. This feature allows for faster healing without the need for ongoing wound care by patients or nurses, which is different from many traditional dressings that require frequent changes and monitoring. ^{1 3 4 5 8}

Research Team

Saxe Johathan, MD

Principal Investigator

Altrazeal Life Sciences Inc

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Altrazeal® Transforming Powder Dressing

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of a transforming powder dressing in the lower leg wounds of two older patients: case studies. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a new pressure ulcer preventive dressing containing ceramide 2 with low frictional outer layer. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

A New Powder Dressing for Management of Chronic Venous Ulcers. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Rapid, economical healing of two large Mohs surgery wounds with transforming powder dressing. [2020]

6. England 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. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

A Net Meta-Analysis of the Effectiveness of Different Types of Dressings in the Treatment of Diabetic Foot. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Comparing two dressings in the treatment of diabetic foot ulcers. [2019]