Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ULURU Inc.
- 入组人数
- 135
- 试验地点
- 24
- 主要终点
- Incidence of wound closure
研究概览
简要总结
Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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%
结局指标
主要结局
Incidence of wound closure
时间窗: 12 weeks
Compare rate of complete wound healing in diabetic foot wounds between the two study groups
次要结局
- Adverse Events(12 weeks)
- Clinician Acceptability(12 weeks)
- Quality of Life while living with a wound(12 weeks)
- Subject Satisfaction(12 weeks)
- Wound pain(12 weeks)
- Wound healing trajectories and time to wound closure(12 weeks)