Development and Testing of a New Generation of Diabetic Footwear (DiaBSmart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01816906
Recruitment Status : Unknown
Verified May 2016 by Nachiappan Chockalingam, Staffordshire University.
Recruitment status was:  Active, not recruiting
First Posted : March 22, 2013
Last Update Posted : May 18, 2016
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Information provided by (Responsible Party):
Nachiappan Chockalingam, Staffordshire University

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

Condition or disease Intervention/treatment Phase
Diabetes Complications Diabetic Neuropathies Device: Footwear :PU Device: Footwear: MCP Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials
Study Start Date : May 2012
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: MCP Insole
The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.
Device: Footwear: MCP
One group of patients will receive footwear with MCP insoles

Active Comparator: PU insole
The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.
Device: Footwear :PU
One group of patients will receive "Footwear" with PU insoles

Primary Outcome Measures :
  1. Change in Plantar pressure during walking [ Time Frame: Upto 12 months ]
    Specific data collection points are: Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013

Secondary Outcome Measures :
  1. Change in Ankle strength and range of motion [ Time Frame: Upto 12 months ]
    Specific data collection points are:Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013

  2. Change in Postural sway during standing [ Time Frame: Upto 12 months ]
    Specific data collection points are: Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013

Other Outcome Measures:
  1. Change in Vibration Perception Threshold and Neuropathy score [ Time Frame: Upto 12 months ]
    Specific data collection points are: Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01816906

IDRF/ AR Hopsitals
Chennai, Tamilnadu, India, 600008
Sponsors and Collaborators
Staffordshire University
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Principal Investigator: Nachiappan Chockalingam, PhD Staffordshire University
Study Director: Lakshmi Sundar, MBBS AR Hospitals/ IDRF
Study Director: Roozbeh Naemi, PhD Staffordshire University

Responsible Party: Nachiappan Chockalingam, Director, Biomechanics Facility, Staffordshire University Identifier: NCT01816906     History of Changes
Other Study ID Numbers: DiaBSmart-01
DiaBSmart -2011-IAPP ( Other Grant/Funding Number: FP7-PEOPLE-2011-IAPP Grant Agreement Number 285985 )
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Diabetic Neuropathies
Diabetes Complications
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases