Transforming Powder Dressing vs Standard Care for Foot Ulcer

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byLawrence Lavery, DPM, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: ULURU Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Wound drainage is minimal or moderate

Able and willing to provide consent

Has not participated in another research trial within 3 months of enrollment.

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Exclusion Criteria

Oral steroid use in last 3 months

Unable to sign consent

Unable or unwilling to use offloading device if recommended

See 20 more

Treatment Details

Interventions

Standard of care topical wound agents and dressings (Wound Dressing)
Transforming Powder Dressing (Wound Dressing)

Trial OverviewThe 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.

Participant Groups

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.