Diabetic Foot Ulcer
Conditions
Keywords
Standard of Care Wound Dressings, Transforming Powder Dressing, Diabetic Foot Ulcers, Altrazeal
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.
Interventions
DEVICETransforming 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.
OTHERStandard 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.
Sponsors
Naval Medical Research Center
Military Technology Enterprise Consortium (US)
ULURU Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Prospective, Multi-Center, Open-Label, Comparison, Human, Interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound closure | 12 weeks | Compare rate of complete wound healing in diabetic foot wounds between the two study groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 weeks | Safety as indicated by adverse events (new or worsening conditions) and frequency of wound infections |
| 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 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 |
| 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) |
| Clinician Acceptability | 12 weeks | Based on clinician survey completed at end of study (8 questions total, multiple choice or 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. |
Countries
United States
Outcome results
None listed