DRKS00005683已完成未知
Smart insole for patients with diabetic neuropathy for the prevention of foot ulcers - Insole
Otto-von-Guericke Universität, Medizinsiche Fakultät0 个研究点目标入组 64 人开始时间: 2014年1月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria for the healthy subjects:
- •- No macroangiopathy or skin defects of the lower extremities
- •- No polyneuropathy any etiology
- •- No diabetes mellitus
- •- No physical deformities (amputations, foot, leg, spinal deformities, etc.)
- •- No neuropathic ulceration in the foot
- •- No heart failure St. III / IV according to NYHA
- •- No myocardial infarction = 12 weeks ago
- •- Capacity to consent
- •- Written consent after being informed
- •Inclusion criteria for subjects with neuropathy:
- •- Diabetes mellitus type 1 or type 2
- •- Sensorimotor peripheral neuropathy (vibration perception by means of graduated tuning fork according to Rydel / Seiffer - Good general condition
- •- Absence of foot deformities requiring orthopedic shoes
- •- Absence of neuropathic ulcers or other wounds
- •- Absence of macroangiopathy of the lower extremities
排除标准
- •Exclusion criteria for subjects with neuropathy:
- •- Neuropathic ulcers in the foot
- •- Macroangiopathy of the lower extremities
- •- St. heart failure III / IV according to NYHA
- •- Physical deformities (amputations, foot, leg, spinal deformities, etc.)
- •- Myocardial infarction = 12 weeks ago
- •- Lack of capacity to consent
- •- Lack of written consent after being informed
研究者
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