Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Key facts
- Who runs it
- ULURU Inc.
- Where
- Baltimore, Dallas, Houston, Lake Success, Rossville, The Bronx, Wappingers Falls, Washington D.C., and Winter Park, United StatesSee the 12 sites
- Trial code
- Status
- Completed
- People taking part
- 135 people enrolled
- Started
- 16 Aug 2021
- Ended
- 6 Nov 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Transforming Powder Dressing
- Standard of care topical wound agents and dressings
- Record updated
- 19 November 2025
Who can take part
- Age
- 18 years to 89 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 18-89 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
Who cannot take part
- Wounds impending surgical intervention (including revascularization or plastic surgery)
- Oral steroid use in last 3 months
- Soft tissue infection (can be enrolled once infection is cleared)
- History of AIDS
- History of organ transplant or impending transplant
- End stage renal disease requiring dialysis
- Decompensated hepatic or cardiac disease
- Select autoimmune diseases
- Venous stasis disease
- Active malignancy (cancer)
- Hemoglobin A1C >12%
- Unable to keep weekly research appointments
- Unable or unwilling to use offloading device if recommended
- Wounds with large amount (high) drainage
- Active gangrene
- Untreated osteomyelitis
- Active Charcot arthropathy
- BMI >45kg/m2
- Lymphedema
- Unable to sign consent
- Active alcohol or substance abuse
- Pregnant or lactating women
- Insufficient vascular flow to heal a wound
Where in United States
- MedStar Good Samaritan HospitalBaltimore, United States
- VA Maryland Health Care SystemBaltimore, United States
- Dallas Veteran's Administration Medical CenterDallas, United States
- Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390Houston, United States
- Northwell Health Wound Healing CenterLake Success, United States
- MedStar Franklin SquareRossville, United States
- Bronx Foot CareThe Bronx, United States
- James J Peters VA Medical CenterThe Bronx, United States
- VA Hudson Valley Healthcare SystemWappingers Falls, United States
- MedStar Georgetown University HospitalWashington D.C., United States
- MedStar Washington Hospital CenterWashington D.C., United States
- AdventHealth Medical Group Foot & Ankle at Winter ParkWinter Park, United States
About the trial
What the trial wants to find out
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
The 2 groups in the trial
- Transforming Powder DressingExisting treatment, for comparison
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.
- Standard of Care DressingExisting treatment, for comparison
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.
Treatment: Standard of care topical wound agents and dressings
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
- Record updated
- 19 November 2025