NCT02675855已完成4 期
A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Complete closure of index wound
研究概览
简要总结
The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 Diabetes
- •Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks)
- •Index ulcer located below the malleoli on the plantar or dorsal surface of the foot
- •Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule
- •Adequate circulation to the foot (documented by ABI or TBI)
排除标准
- •Gangrene present on affected foot
- •Index ulcer is over a Charcot deformity
- •Patient is receiving dialysis
- •Patient has 2 or more previous amputations
- •Patient has HbA1c >12% or random blood sugar >450 mg/dl
- •Chronic oral steroid use
- •Use of IV corticosteroid, immunosuppressive, or cytotoxic agents
- •IV antibiotics
- •Another ulcer within 5cm of the Index ulcer
- •Cellulitis, evidence of infection, or osteomyelitis
研究组 & 干预措施
GrafixPRIME®
Experimental
GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices
干预措施: GrafixPRIME® (Other)
GrafixPRIME®
Experimental
GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices
干预措施: Off-loading (walking boot) (Device)
Active Comparator
Active Comparator
Wound cover, Dressing Application Patients will be fitted with off-loading devices
干预措施: Dressing Application (Procedure)
Active Comparator
Active Comparator
Wound cover, Dressing Application Patients will be fitted with off-loading devices
干预措施: Off-loading (walking boot) (Device)
结局指标
主要结局
Complete closure of index wound
时间窗: Up to Day 56
次要结局
- Time to wound closure(Up to Day 56)
- Proportion of patients that achieve a 50% reduction or greater in wound size(Day 28)
- Number of product applications(Up to Day 56)
- Number of Adverse Events(Up to Day 56)
- Number of patients with worsening of wound by ≥50% increase in size(Up to Day 56)
研究者
研究点 (3)
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