NCT01265420已完成4 期
The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
研究概览
简要总结
This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Adult subjects (> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of > 20 degrees of the thumb
- •First web space contracture with a palpable cord due to Dupuytren's contracture
排除标准
- •Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.
- •Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
- •Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
- •Any subject with known allergy to Xiaflex (Clostridial collagenase).
- •Pregnant or nursing female
- •Any subject who cannot conform to the study visit schedule
研究组 & 干预措施
Injectable clostridial collagenase
Experimental
Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase
干预措施: Injectable clostridial collagenase (Biological)
结局指标
主要结局
Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
时间窗: 30 days after last injection
次要结局
未报告次要终点
研究者
F. Thomas D. Kaplan, MD
MD
Indiana Hand to Shoulder Center
研究点 (1)
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