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Intelligent sensor-equipped shoe insole for patients with diabetic neuropathy for prophylaxis of foot ulcers (ulcer) - ISS
Otto-von-Giericke University MagdeburgMedical Faculty0 个研究点目标入组 286 人开始时间: 2018年1月18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
- 286
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Diabetes mellitus type 1 or type 2
- •- ages between 18 and 85 years
- •- Sensomotoric peripheral diabetic polyneuropathy (sensation of vibration by means of a graduated tuning fork according to Rydel / Seiffer - Missing neuropathic ulcers in the foot area in the anamnesis (risk group 2) or healed neuropathic ulcers in the foot area in the anamnesis (risk group 3)
- •- Good general condition
- •- capacity to consent
- •- written consent after clarification
- •- Dealing with mobile phone and app after instruction possible
排除标准
- •- Existing foot ulcers at the beginning of the clinical trial
- •- Macroangiopathy of the lower extremities (ABI <0.5)
- •- Risk group 0-1 according to the classification system for shoe care and risk assessment in diabetic foot syndrome [9]
- •- heart failure St. III / IV according to NYHA
- •- Active tumor disease
- •- Physical deformities (amputations, foot, leg, spinal deformities affecting the gait)
- •- Visual impairment, so that the use of an app using a tablet can not be performed
- •- Myocardial infarction before = 12 weeks
- •- pregnancy
- •- Any other reason that, in the opinion of the investigator, precludes participation.
研究者
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