This trial is active, not recruiting.

Conditions diabetes complications, diabetic neuropathies
Treatments footwear :pu, footwear: mcp
Sponsor Staffordshire University
Collaborator India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Start date May 2012
End date April 2016
Trial size 70 participants
Trial identifier NCT01816906, DiaBSmart -2011-IAPP, DiaBSmart-01


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.
footwear: mcp
One group of patients will receive footwear with MCP insoles
(Active Comparator)
The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.
footwear :pu
One group of patients will receive "Footwear" with PU insoles

Primary Outcomes

Change in Plantar pressure during walking
time frame: Upto 12 months

Secondary Outcomes

Change in Ankle strength and range of motion
time frame: Upto 12 months
Change in Postural sway during standing
time frame: Upto 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials
Principal investigator Nachiappan Chockalingam, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Staffordshire University.