A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 36
- 主要终点
- Complete wound closure
研究概览
简要总结
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.
详细描述
This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I or Type II diabetes
- •A diabetic foot ulcer located on the foot or ankle at least one square centimeter
排除标准
- •Suspected or confirmed signs/symptoms of wound infection
- •Hypersensitivity to bovine collagen
结局指标
主要结局
Complete wound closure
时间窗: by 12 weeks
次要结局
- Change in quality of life measurements between PriMatrix and Standard of Care(between baseline and 24 weeks)
- Change in predicted medical expenditures between PriMatrix and Standard of Care(over 24 weeks)
- Nonserious and serious adverse events(over 24 weeks)