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

March 11, 2019 updated by: Nachiappan Chockalingam, Staffordshire University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600008
        • IDRF/ AR Hopsitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle Strength Left 1
Time Frame: Up to 6 months
Strength during dorsi flexion using Citec Dynamometer
Up to 6 months
Ankle Strength Left 2
Time Frame: Up to 6 months
Strength during plantar flexion using Citec Dynamometer
Up to 6 months
Ankle Strength Right 1
Time Frame: Up to 6 months
Strength during dorsi flexion using Citec Dynamometer
Up to 6 months
Ankle Strength Right 2
Time Frame: Up to 6 months
Strength during plantar flexion using Citec Dynamometer
Up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vibration Perception Threshold
Time Frame: Up to 6 months
Average of left and right (8 measurement areas per foot)
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Staffordshire University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Actual)

June 14, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiaBSmart-01
  • DiaBSmart -2011-IAPP (Other Grant/Funding Number: FP7-PEOPLE-2011-IAPP Grant Agreement Number 285985)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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