NL-OMON52218已完成不适用
Individually optimized rocker profile and self-adapting insole to reduce the plantar peak pressure in Diabetic patients with loss of protective sensation - combination: optimized rocker profile and self-adapting insole
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For the Diabetic patients:
- •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 Diabetic patients:
- •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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