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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 : Completed
First Posted : March 22, 2013
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 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
Actual Study Start Date : April 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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. 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 Outcome Measures :
  1. Ankle Strength Left 1 [ Time Frame: Up to 6 months ]
    Strength during dorsi flexion using Citec Dynamometer

  2. Ankle Strength Left 2 [ Time Frame: Up to 6 months ]
    Strength during plantar flexion using Citec Dynamometer

  3. Ankle Strength Right 1 [ Time Frame: Up to 6 months ]
    Strength during dorsi flexion using Citec Dynamometer

  4. Ankle Strength Right 2 [ Time Frame: Up to 6 months ]
    Strength during plantar flexion using Citec Dynamometer

Other Outcome Measures:
  1. Vibration Perception Threshold [ Time Frame: Up to 6 months ]
    Average of left and right (8 measurement areas per foot)

Information from the National Library of Medicine

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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

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

Additional Information:
Publications of Results:
Naemi, R., Linyard-Tough, K., Healy, A. and Chockalingam, N., 2015. The influence of slow recovery insole on plantar pressure and contact area during walking. Journal of Mechanics in Medicine and Biology, 15(02), p.1540005.

Other Publications:
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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
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetes Complications
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases