A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Percent of study ulcers healed
研究概览
简要总结
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.
详细描述
Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 years of age and able to give their own consent
- •Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
- •Study ulcer has a Wagner grade of 1 or 2
- •Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
- •A full thickness diabetic foot ulcer located on the foot or ankle
- •An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.
排除标准
- •Suspected or confirmed signs/symptoms of wound infection
- •Wounds with exposed bone or tendon
- •Hypersensitivity to bovine collagen
研究组 & 干预措施
Treatment
PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.
干预措施: PriMatrix (Device)
Standard of Care
Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.
干预措施: Standard of Care (Other)
结局指标
主要结局
Percent of study ulcers healed
时间窗: 12 weeks post-randomization
Percent of study ulcers healed at week 12 post-randomization
次要结局
- Cost of Treatment(12 weeks)