NCT00304733Unknown不适用
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Rehabilitation Centre Amsterdam2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2001年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- wound surface area reduction
研究概览
简要总结
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
详细描述
In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
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
- •confirmed diabetes
- •neuropathic ulcer grade 1/2 (wagner scale)
- •confirmed sensory neuropathy
排除标准
- •osteomyelitis patients unable to walk
- •life threatening co-morbidity ankle/brachial index , 0.4
结局指标
主要结局
wound surface area reduction
次要结局
- time to wound healing (days)
研究者
研究点 (2)
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