NCT05046158

Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: ULURU Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.

Detailed description

Diabetic men and women aged 18-89 years, who have a diabetic foot ulcer present for a minimum of 30 days will be considered for the study. Subjects will be randomized to either standard of care wound dressings or transforming powder dressing. Half of the subjects will receive standard of care dressings, and the other half will receive transforming powder dressing in a 1:1 randomization process at each of the study sites. Subjects will present to the study center weekly for up to 12 weeks (less time if the wound heals prior to 12 weeks). The last study visit occurs 12 weeks after the End of Study visit.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Transforming Powder Dressing	Altrazeal transforming powder dressing is methacrylate-based powder dressing made from the same materials used in the production of contact lenses. Upon hydration, the powder transforms into a moist, non-occlusive barrier that covers and protects the wound from exogenous bacteria while helping manage exudate through vapor transpiration.
OTHER	Standard of care topical wound agents and dressings	Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.

Timeline

• Start date: 2021-08-16
• Primary completion: 2025-11-06
• Completion: 2025-11-06
• First posted: 2021-09-16
• Last updated: 2025-11-19

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study