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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
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.
Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Medical Group Foot & Ankle at Winter Park
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Winter Park, Florida, United States
VA Maryland Health Care System
Baltimore, Maryland, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States
MedStar Franklin Square
Rossville, Maryland, United States
Northwell Health Wound Healing Center
Lake Success, New York, United States
Bronx Foot Care
The Bronx, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
VA Hudson Valley HealthCare System
Wappingers Falls, New York, United States
...and 2 more locations
Time frame: 12 weeks