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临床试验/NCT01816906
NCT01816906已完成不适用

Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials

Staffordshire University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2012年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Postural Sway During Shod Standing

研究概览

简要总结

This particular trial is looking to compare the effectiveness of two types of foot bed/ sole materials used within diabetic footwear.

详细描述

DiaBSmart as a project aims to generate, transfer and exchange the clinical, academic and production knowledge between the partners to create a new generation of diabetic footwear through a newly developed patient assessment system. The transfer of knowledge between various sectors ensures that the need of patients is considered and transferred effectively to product development using a scientific approach. The objectives include:(1) the design and development of an integrated system of DIABetic foot assessment (2) to validate the newly developed system using experimental methods (3) to develop a suitable material to meet the mechanical and clinical requirements (4) to evaluate the mechanical and clinical effectiveness of material choice in reducing the potential risk of foot complications. The Numerical, Experimental and Mathematical Analyses system will integrate all aspects of diabetic footwear including; clinical and biomechanical assessment, material choice and aesthetic design. Proposed interdisciplinary, inter-sectorial approach is unique and brings together the expertise from research institutions, industry and clinics. This project while enhancing the knowledge base in diabetic assessment; will have a clear impact on new product development leading to both clinical and economic benefits. The products include a new generation of integrated SMART /multi material midsoles and/or orthoses for diabetic footwear. Properties of the materials will be optimised with a view to minimise/ redistribute the pressure and hence the stress on the soft tissue in the critical plantar areas of the foot. Whilst significantly affecting the course of the disease, the products will aim to reduce the risk of limb loss in patients with diabetes, the most frequent cause of non-traumatic lower-limb amputations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Diabetes by WHO criteria
  • Lack of sensation to 10 g monofilament or VPT >25 V
  • Ability to walk independently for 10 m
  • No ambulatory status
  • No severe foot deformity like Charcot foot
  • Willingness to be assigned to randomisation of footwear
  • At least one palpable pedal pulse on each foot

排除标准

  • Previous ulceration or current Trophic Ulcers
  • Active foot infection
  • Alzheimer and dementia and impaired cognitive function
  • Gross abnormality or Foot deformity requiring footbed customisation
  • Chronic Kidney Disease
  • Hammer toes
  • Previous foot surgeries

研究组 & 干预措施

MCP Insole

Active Comparator

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

干预措施: Footwear: MCP (Device)

PU insole

Active Comparator

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

干预措施: Footwear :PU (Device)

结局指标

主要结局

Postural Sway During Shod Standing

时间窗: 6 months

Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds. Area of the center of pressure excursion

次要结局

  • Ankle Strength Left 1(Up to 6 months)
  • Ankle Strength Left 2(Up to 6 months)
  • Ankle Strength Right 1(Up to 6 months)
  • Ankle Strength Right 2(Up to 6 months)

研究者

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

Nachiappan Chockalingam

Director, Biomechanics Facility

Staffordshire University

研究点 (2)

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