Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
NCT ID: NCT05046158
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2021-08-16
2025-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transforming Powder Dressing
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.
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.
Standard of Care 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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with diabetes Mellitus; hemoglobin A1C \< 12%
* Diabetic foot ulcer present for minimum 30 days (Wagner grade 1 or 2 classification)
* Wound drainage is minimal or moderate
* No clinically active wound infection
* Able and willing to provide consent
* Has not participated in another research trial within 3 months of enrollment.
Exclusion Criteria
* Unable or unwilling to use offloading device if recommended
* Wounds with large amount (high) drainage
* Active gangrene
* Wounds impending surgical intervention (including revascularization or plastic surgery)
* Untreated osteomyelitis
* Soft tissue infection (can be enrolled once infection is cleared)
* Active Charcot arthropathy
* BMI \>45kg/m2
* History of AIDS
* History of organ transplant or impending transplant
* End stage renal disease requiring dialysis
* Decompensated hepatic or cardiac disease
* Select autoimmune diseases
* Lymphedema
* Oral steroid use in last 3 months
* Venous stasis disease
* Active malignancy (cancer)
* Unable to sign consent
* Active alcohol or substance abuse
* Pregnant or lactating women
* Insufficient vascular flow to heal a wound
* Hemoglobin A1C \>12%
18 Years
89 Years
ALL
No
Sponsors
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Naval Medical Research Center
FED
Military Technology Enterprise Consortium (US)
UNKNOWN
ULURU Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence Lavery, DPM, MPH
Role: PRINCIPAL_INVESTIGATOR
Altrazeal Life Sciences Inc.
Jonathan Saxe, MD
Role: STUDY_DIRECTOR
Altrazeal Life Sciences Inc.
Locations
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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
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
Dallas Veteran's Administration Medical Center
Dallas, Texas, United States
Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390
Houston, Texas, United States
Countries
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References
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Han G, Ceilley R. Chronic Wound Healing: A Review of Current Management and Treatments. Adv Ther. 2017 Mar;34(3):599-610. doi: 10.1007/s12325-017-0478-y. Epub 2017 Jan 21.
Wound Care Awareness Week Highlights of the Chronic Wound Epidemic in U.S. Businesswire.com/news/home/20160607006326/en/Wound-Care-Awareness-Week-Highlights-Chronic-Wound. Accessed 11/5/2020.
Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.
Related Links
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Altrazeal (Transforming Powder Dressing) product information
Other Identifiers
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U-C-TPD-2021-01
Identifier Type: -
Identifier Source: org_study_id
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