Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Device: Transforming Powder DressingOther: Standard of care topical wound agents and dressings
- Registration Number
- NCT05046158
- Lead Sponsor
- ULURU Inc.
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transforming Powder Dressing 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. Standard of Care Dressing Standard of care topical wound agents and dressings 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.
- Primary Outcome Measures
Name Time Method Incidence of wound closure 12 weeks Compare rate of complete wound healing in diabetic foot wounds between the two study groups
- Secondary Outcome Measures
Name Time Method Adverse Events 12 weeks Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections
Clinician Acceptability 12 weeks Based on clinician survey completed at end of study (8 questions total, multiple choice or 7 point Likert scale)
Quality of Life while living with a wound 12 weeks 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)
Subject Satisfaction 12 weeks 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).
Wound pain 12 weeks 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.
Wound healing trajectories and time to wound closure 12 weeks Evaluate differences in wound healing trajectories and time to wound closure between the two study groups
Trial Locations
- Locations (12)
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
James J. Peters VA Medical Center
🇺🇸Bronx, New York, United States
Bronx Foot Care
🇺🇸Bronx, New York, United States
VA Hudson Valley HealthCare System
🇺🇸Wappingers Falls, New York, 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
AdventHealth Medical Group Foot & Ankle at Winter Park
🇺🇸Winter Park, Florida, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Northwell Health Wound Healing Center
🇺🇸Lake Success, 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