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临床试验/NCT01699100
NCT01699100已完成不适用

Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Offloading Technique: Insoles With Peg Assist Design

Taichung Veterans General Hospital0 个研究点目标入组 26 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
主要终点
plantar pressure of region of interest

研究概览

简要总结

The purpose of this study was to determine if insoles with removable pegs could effectively reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for guidance of peg removal.

详细描述

The investigators tested the effect of plantar pressure reduction in four conditions:

  1. insole of the original shoe
  2. peg assist insole but the pegs are not yet removed
  3. peg assist insole and the pegs were removed
  4. condition3. plus arch support to the insole

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • previously diagnosed type 2 diabetes with neuropathic foot were recruited from the outpatient endocrinology and metabolism division of Taichung Veterans General Hospital in central Taiwan

排除标准

  • The exclusion criteria were history of lower extremities amputation, major foot deformities, presence of active plantar foot wound or ulcer, and difficulty walking more than 100 m.

结局指标

主要结局

plantar pressure of region of interest

时间窗: 30 minutes

In-shoe plantar pressure difference between before and after insole use.

次要结局

  • Plantar pressure of non-region of interest(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tung-Liang,Lin

Taichung Veterans General Hospital

Taichung Veterans General Hospital

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