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临床试验/NL-OMON25577
NL-OMON25577招募中不适用

Individually optimized rocker profile and self-adapting insole to reduce the plantar peakpressure in Diabetic patients with loss of protective sensation

niversity Medical Center Groningen0 个研究点目标入组 35 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
35

研究概览

简要总结

/A

研究设计

研究类型
Interventional

入排标准

入选标准

  • For the patients with Diabetes Mellitus:
  • - Diabetes mellitus (type I or II)
  • - Loss of protective sensation (10 gr filament & 128Hz tunning fork)
  • - Ambulatory without use of walking aids (with the exception of the use of orthopaedic footwear)
  • - Shoe size between 36 and 46
  • For the healthy reference group:
  • - Ambulatory without use of walking aids
  • - Age between 40-70 year
  • - Shoe size between 36-46

排除标准

  • For the patients with Diabetes Mellitus:
  • - Current ulcer(s) and ulcer(s) in the past
  • - Use of walking aids (with the exception of the use of orthopaedic footwear)
  • - Extreme foot deformations (e.g. Charcot foot) or toe or foot amputations that do not allow participants to fit semi-ready-to-wear shoes
  • - Body weight >130kg
  • For the healthy reference group:
  • - Use of walking aids
  • - Foot complications (injuries that can influence gait) that do not allow participants to fit ready-to-wear shoes
  • - Body weight >130kg
  • - Any self-reported injury or disease that affects walking ability

研究者

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