This particular trial is looking to compare the effectiveness of two types of foot bed/ sole materials used within diabetic footwear.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
82
One group of patients will receive "Footwear" with PU insoles
One group of patients will receive footwear with MCP insoles
IDRF/ AR Hopsitals
Chennai, Tamil Nadu, India
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
Time frame: 6 months
Ankle Strength Left 1
Strength during dorsi flexion using Citec Dynamometer
Time frame: Up to 6 months
Ankle Strength Left 2
Strength during plantar flexion using Citec Dynamometer
Time frame: Up to 6 months
Ankle Strength Right 1
Strength during dorsi flexion using Citec Dynamometer
Time frame: Up to 6 months
Ankle Strength Right 2
Strength during plantar flexion using Citec Dynamometer
Time frame: Up to 6 months
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