What side effects are associated with this type of intervention?

Common treatments for foot ulcers that create a moist environment and deliver bioactive compounds include hydrocolloid dressings, alginate dressings, and antimicrobial dressings. Known side effects of these treatments can include local skin irritation, allergic reactions, and, in some cases, maceration of the surrounding skin due to excessive moisture. Additionally, antimicrobial dressings may cause contact dermatitis or delayed wound healing if used improperly.

What prior FDA approvals exist?

Several FDA-approved treatments for foot ulcers focus on creating a moist wound environment and delivering bioactive compounds to promote healing. Notable examples include hydrocolloid dressings, which maintain a moist environment conducive to healing, and silver-impregnated dressings that provide antimicrobial activity. Additionally, growth factor therapies like becaplermin gel (Regranex) have been approved, which deliver bioactive compounds to stimulate tissue repair. These treatments share similarities with the Transforming Powder Dressing in their approach to enhancing wound healing through moisture retention and bioactive delivery.

What other types of research exist?

Promising novel alternatives to Transforming Powder Dressing for foot ulcer patients include: <ol> <li>Platelet-Rich Plasma (PRP) Injections: PRP contains growth factors that may stimulate tissue repair and has shown some efficacy in wound healing.</li> <li></li> </ol> Stem Cell Therapy: Stem cells can promote tissue regeneration and have been used in various clinical applications, including wound healing. 3. Topical Nitroglycerin: This treatment may improve collagen synthesis and has shown clinical improvements in chronic tendinopathies, which could be beneficial for wound healing. 4. Low-Level Laser Therapy (LLLT): LLLT has been reported to improve healing and symptoms in various conditions, including wound healing. 5. Negative Pressure Wound Therapy (NPWT): This method creates a moist environment and promotes wound healing by applying controlled negative pressure to the wound site.

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Wound Dressing

Transforming Powder Dressing vs Standard Care for Foot Ulcer

N/A

Recruiting

Led By Lawrence Lavery, DPM, MPH

Research Sponsored by ULURU Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Wound drainage is minimal or moderate

Able and willing to provide consent

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a special healing powder to regular wound dressings for diabetic patients with foot ulcers. The powder aims to help wounds heal faster by keeping them clean and supporting skin recovery.

Who is the study for?

This trial is for adults aged 18-89 with diabetes and a diabetic foot ulcer that's lasted at least 30 days. They should have controlled blood sugar (Hemoglobin A1C <12%) and be able to attend weekly appointments. People with severe illnesses, high BMI (>45), recent steroid use, or heavy wound drainage cannot participate.

What is being tested?

The study compares a new Transforming Powder Dressing against standard care dressings in healing diabetic foot ulcers. It's a Phase IV trial where participants are randomly chosen to receive one of the treatments and monitored over time.

What are the potential side effects?

While specific side effects aren't listed, typical risks may include skin irritation, allergic reactions to dressing materials, or infection due to improper wound management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of wound closure

Secondary study objectives

Adverse Events

Clinician Acceptability

Quality of Life while living with a wound

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard of Care DressingActive Control1 Intervention

Half of the subjects will be randomized to receive standard of care wound dressings to treat their diabetic foot ulcers. Wounds will be evaluated weekly, debrided if needed, photographed, and measured. A wound dressing will be applied using standard of care wound products, and the wound will be offloaded when necessary (pressure taken off of the wound using a total contact cast or other device). Wound healing progress will be monitored and compared to transforming powder dressings used to treat diabetic foot ulcers. Surveys regarding pain and quality of life will be completed at each study visit.

Group II: Transforming Powder DressingActive Control1 Intervention

Half of the subjects will be randomized to Transforming Powder Dressing to treat their diabetic foot ulcers. Wounds will be evaluated weekly, debrided if needed, photographed, and measured. A wound dressing will be applied using Transforming Powder Dressing and the wound will be offloaded when necessary (pressure taken off of the wound using a total contact cast or other device). Wound healing progress will be monitored and compared to other standard of care dressings used to treat diabetic foot ulcers.Surveys regarding pain and quality of life will be completed at each study visit.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for foot ulcers, such as transforming powder dressings, work by creating a moist environment that promotes wound healing. This moist environment is essential as it facilitates cell migration, collagen formation, and tissue regeneration. Additionally, these dressings can deliver bioactive compounds directly to the wound site, which can further enhance healing by reducing inflammation, preventing infection, and stimulating tissue repair. For foot ulcer patients, these mechanisms are vital as they can significantly accelerate the healing process, reduce complications, and improve the quality of life.