Development and Testing of a New Generation of Diabetic Footwear

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

Detailed Description
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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.

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

Conditions
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Diabetes Complications, Diabetic Neuropathies

Intervention / Treatment
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* Device: Footwear :PU
* Device: Footwear: MCP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MCP Insole<br>The intervention is Footwear: MCP. MCP insoles are commonly used within Diabetic sandals in India. | Device: Footwear: MCP<br>* One group of patients will receive footwear with MCP insoles<br>|
| Active Comparator: PU insole<br>The intervention is Footwear: PU. Insoles made of Polyurethane(PU) are given to the participants in the intervention arm. | Device: Footwear :PU<br>* One group of patients will receive Footwear with PU insoles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Sway During Shod Standing | 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 | Strength during dorsi flexion using Citec Dynamometer | Up to 6 months | 
| Ankle Strength Left 2 | Strength during plantar flexion using Citec Dynamometer | Up to 6 months | 
| Ankle Strength Right 1 | Strength during dorsi flexion using Citec Dynamometer | Up to 6 months | 
| Ankle Strength Right 2 | Strength during plantar flexion using Citec Dynamometer | Up to 6 months |