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

This study is currently recruiting participants.
Verified April 2013 by Staffordshire University
Sponsor:
Collaborator:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Information provided by (Responsible Party):
Nachiappan Chockalingam, Staffordshire University
ClinicalTrials.gov Identifier:
NCT01816906
First received: March 14, 2013
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Diabetes Complications
Diabetic Neuropathies
Device: Footwear :PU
Device: Footwear: MCP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials

Resource links provided by NLM:


Further study details as provided by Staffordshire University:

Primary Outcome Measures:
  • Change in Plantar pressure during walking [ Time Frame: Upto 12 months ] [ Designated as safety issue: No ]
    Specific data collection points are: Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013


Secondary Outcome Measures:
  • Change in Ankle strength and range of motion [ Time Frame: Upto 12 months ] [ Designated as safety issue: No ]
    Specific data collection points are:Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013

  • Change in Postural sway during standing [ Time Frame: Upto 12 months ] [ Designated as safety issue: No ]
    Specific data collection points are: Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013


Other Outcome Measures:
  • Change in Vibration Perception Threshold and Neuropathy score [ Time Frame: Upto 12 months ] [ Designated as safety issue: No ]
    Specific data collection points are: Jul 2012, Oct 2012, Jan 2013, Apr 2013, Jul 2013


Estimated Enrollment: 70
Study Start Date: May 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01816906

Contacts
Contact: Nachiappan Chockalingam, PhD +441782295853 n.chockalingam@staffs.ac.uk
Contact: Lakshmi Sundar, MBBS sundarlakshmi@hotmail.com

Locations
India
IDRF/ AR Hopsitals Recruiting
Chennai, Tamilnadu, India, 600008
Contact: Lakshmi Sundar, MBBS       sundarlakshmi@hotmail.com   
Principal Investigator: Lakshmi Sundar, MBBS         
Sub-Investigator: Aoife Healy, MSc         
Sub-Investigator: Anju K Pillai         
Sponsors and Collaborators
Staffordshire University
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Investigators
Principal Investigator: Nachiappan Chockalingam, PhD Staffordshire University
Study Director: Lakshmi Sundar, MBBS AR Hospitals/ IDRF
Study Director: Roozbeh Naemi, PhD Staffordshire University
  More Information

No publications provided

Responsible Party: Nachiappan Chockalingam, Director, Biomechanics Facility, Staffordshire University
ClinicalTrials.gov Identifier: NCT01816906     History of Changes
Other Study ID Numbers: DiaBSmart-01, DiaBSmart -2011-IAPP
Study First Received: March 14, 2013
Last Updated: April 4, 2013
Health Authority: India: Indian Council of Medical Research

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

ClinicalTrials.gov processed this record on April 23, 2014