Development and Testing of a New Generation of Diabetic Footwear

Not Applicable

Completed

Conditions: Diabetes Complications
Diabetic Neuropathies

Registration Number: NCT01816906

Lead Sponsor: Staffordshire University

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postural Sway During Shod Standing	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

Secondary Outcome Measures

Name	Time	Method
Ankle Strength Left 1	Up to 6 months	Strength during dorsi flexion using Citec Dynamometer
Ankle Strength Left 2	Up to 6 months	Strength during plantar flexion using Citec Dynamometer
Ankle Strength Right 1	Up to 6 months	Strength during dorsi flexion using Citec Dynamometer
Ankle Strength Right 2	Up to 6 months	Strength during plantar flexion using Citec Dynamometer