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

Staffordshire University

Status: Completed

Conditions: Diabetes Complications; Diabetic Neuropathies

Treatments: Device: Footwear :PU; Device: Footwear: MCP

Study type: Interventional

Funder types: Other

Identifiers

NCT01816906

DiaBSmart -2011-IAPP (Other Grant/Funding Number)

DiaBSmart-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

MCP Insole

Active Comparator group

Description:

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Treatment:

Device: Footwear: MCP

PU insole

Active Comparator group

Description:

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Treatment:

Device: Footwear :PU