NCT00804414已完成3 期
A Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Soluble Beta-1,3/1,6-glucan (SBG) in Chronic Foot Ulcers in Patients With Diabetes
Biotec Pharmacon ASA1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Compare the proportion of patients in the two arms who have complete healing of target ulcer
研究概览
简要总结
Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.
详细描述
The objective of this study is to evaluate efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on chronic diabetic foot ulcers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with chronic diabetic foot ulcer
排除标准
- •Insufficient nutritional status, renal function or diabetes control
研究组 & 干预措施
1
Experimental
干预措施: SBG (Drug)
2
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Compare the proportion of patients in the two arms who have complete healing of target ulcer
时间窗: Maximum 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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