An interventional study of Transforming Powder Dressing and Standard of care topical wound agents and dressings in Diabetic Foot Ulcer, sponsored by ULURU Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by ULURU Inc. · Not applicable, Interventional, and Treatment
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 135 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →ULURU Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Device: Transforming Powder Dressing
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.
Other: Standard of care topical wound agents and dressings
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.
Also known as: Altrazeal
Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.
Incidence of wound closure
Compare rate of complete wound healing in diabetic foot wounds between the two study groups
Time frame: 12 weeks
Wound healing trajectories and time to wound closure
Evaluate differences in wound healing trajectories and time to wound closure between the two study groups
Time frame: 12 weeks
Adverse Events
Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
Time frame: 12 weeks
Subject Satisfaction
Evaluate subject satisfaction of wound care products based on "Research subject satisfaction survey" completed at the end of study (8 questions total using a 7 point Likert scale).
Time frame: 12 weeks
Wound pain
Compare differences in pain between the groups based on results of a validated 10 point "Visual Analogue Pain Scale" completed at each visit by all subjects. More pain is indicated by higher scores.
Time frame: 12 weeks
Quality of Life while living with a wound
Compare differences in quality of life between the groups based on results of completed validated "Wound Quality of Life Questionnaire for Chronic Wounds" (17 questions total, answering a 5 point scale \[not at all to very much\], results from answers based on formula)
Time frame: 12 weeks
Clinician Acceptability
Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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ULURU Inc.