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Clinical Trials/NCT01816906
NCT01816906CompletedNot Applicable

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

Staffordshire University2 sites in 1 country82 target enrollmentStarted: April 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
2
Primary Endpoint
Postural Sway During Shod Standing

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

MCP Insole

Active Comparator

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

Intervention: 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.

Intervention: Footwear :PU (Device)

Outcomes

Primary Outcomes

Postural Sway During Shod Standing

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nachiappan Chockalingam

Director, Biomechanics Facility

Staffordshire University

Study Sites (2)

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