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
1 other identifier
interventional
135
1 country
12
Brief Summary
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2021
CompletedFirst Submitted
Initial submission to the registry
August 17, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2025
CompletedNovember 19, 2025
November 1, 2025
4.2 years
August 17, 2021
November 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of wound closure
Compare rate of complete wound healing in diabetic foot wounds between the two study groups
12 weeks
Secondary Outcomes (6)
Wound healing trajectories and time to wound closure
12 weeks
Adverse Events
12 weeks
Subject Satisfaction
12 weeks
Wound pain
12 weeks
Quality of Life while living with a wound
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Transforming Powder Dressing
ACTIVE COMPARATORHalf 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.
Standard of Care Dressing
ACTIVE COMPARATORHalf 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old
- 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.
You may not qualify if:
- Unable to keep weekly research appointments
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ULURU Inc.lead
- Naval Medical Research Centercollaborator
- Military Technology Enterprise Consortium (US)collaborator
Study Sites (12)
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
AdventHealth Medical Group Foot & Ankle at Winter Park
Winter Park, Florida, 32792, United States
VA Maryland Health Care System
Baltimore, Maryland, 21201-1524, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21230, United States
MedStar Franklin Square
Rossville, Maryland, 21237, United States
Northwell Health Wound Healing Center
Lake Success, New York, 11042, United States
Bronx Foot Care
The Bronx, New York, 10462, United States
James J. Peters VA Medical Center
The Bronx, New York, 10468-3904, United States
VA Hudson Valley HealthCare System
Wappingers Falls, New York, 12590, United States
Dallas Veteran's Administration Medical Center
Dallas, Texas, 75216, United States
Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390
Houston, Texas, 77030, United States
Related Publications (3)
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.
PMID: 32176447BACKGROUNDHan 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.
PMID: 28108895BACKGROUNDWound 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence Lavery, DPM, MPH
Altrazeal Life Sciences Inc.
- STUDY DIRECTOR
Jonathan Saxe, MD
Altrazeal Life Sciences Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2021
First Posted
September 16, 2021
Study Start
August 16, 2021
Primary Completion
November 6, 2025
Study Completion
November 6, 2025
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share