Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care
Diabetic Foot Ulcer
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Standard of Care Wound Dressings, Transforming Powder Dressing, Diabetic Foot Ulcers, Altrazeal
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%
Sites / Locations
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- AdventHealth Medical Group Foot & Ankle at Winter Park
- VA Maryland Health Care System
- MedStar Good Samaritan HospitalRecruiting
- MedStar Franklin SquareRecruiting
- Bronx Foot CareRecruiting
- James J. Peters VA Medical CenterRecruiting
- Northwell Health Wound Healing CenterRecruiting
- VA Hudson Valley HealthCare System
- Dallas Veteran's Administration Medical CenterRecruiting
- Baylor College of Medicine Clinic Hospital McNair (MDHP) BCM390
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Transforming Powder Dressing
Standard of Care 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.
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.