Development and Testing of a New Generation of Diabetic Footwear

Diabetic Neuropathies Clinical Trial

— DiaBSmart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816906
• Other study ID #: DiaBSmart-01
• Secondary ID: DiaBSmart -2011-
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2019
• Source: Staffordshire University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetic Neuropathies

Intervention

Device:
• Footwear :PU
One group of patients will receive "Footwear" with PU insoles
• Footwear: MCP
One group of patients will receive footwear with MCP insoles

Locations

Country	Name	City	State
India	IDRF/ AR Hopsitals	Chennai	Tamilnadu

Sponsors (2)

Lead Sponsor	Collaborator
Staffordshire University	India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Country where clinical trial is conducted

India, 

References & Publications (13)

Blazkiewicz M, Sundar L, Healy A, Ramachandran A, Chockalingam N, Naemi R. Assessment of lower leg muscle force distribution during isometric ankle dorsi and plantar flexion in patients with diabetes: a preliminary study. J Diabetes Complications. 2015 Ma — View Citation

Chatzistergos PE, Naemi R, Chockalingam N. A method for subject-specific modelling and optimisation of the cushioning properties of insole materials used in diabetic footwear. Med Eng Phys. 2015 Jun;37(6):531-8. doi: 10.1016/j.medengphy.2015.03.009. Epub — View Citation

Chatzistergos PE, Naemi R, Chockalingam N. An MRI compatible loading device for the reconstruction of clinically relevant plantar pressure distributions and loading scenarios of the forefoot. Med Eng Phys. 2014 Sep;36(9):1205-11. doi: 10.1016/j.medengphy.2014.06.006. Epub 2014 Jul 7. — View Citation

Chatzistergos PE, Naemi R, Healy A, Gerth P, Chockalingam N. Subject Specific Optimisation of the Stiffness of Footwear Material for Maximum Plantar Pressure Reduction. Ann Biomed Eng. 2017 Aug;45(8):1929-1940. doi: 10.1007/s10439-017-1826-4. Epub 2017 Ma — View Citation

Chatzistergos PE, Naemi R, Sundar L, Ramachandran A, Chockalingam N. The relationship between the mechanical properties of heel-pad and common clinical measures associated with foot ulcers in patients with diabetes. J Diabetes Complications. 2014 Jul-Aug; — View Citation

Healy A, Naemi R, Chockalingam N. The effectiveness of footwear and other removable off-loading devices in the treatment of diabetic foot ulcers: a systematic review. Curr Diabetes Rev. 2014;10(4):215-30. Review. — View Citation

Healy A, Naemi R, Chockalingam N. The effectiveness of footwear as an intervention to prevent or to reduce biomechanical risk factors associated with diabetic foot ulceration: a systematic review. J Diabetes Complications. 2013 Jul-Aug;27(4):391-400. doi: 10.1016/j.jdiacomp.2013.03.001. Epub 2013 May 1. Review. — View Citation

Healy A, Naemi R, Sundar L, Chatzistergos P, Ramachandran A, Chockalingam N. Hallux plantar flexor strength in people with diabetic neuropathy: Validation of a simple clinical test. Diabetes Res Clin Pract. 2018 Oct;144:1-9. doi: 10.1016/j.diabres.2018.07 — View Citation

Naemi R, Chatzistergos P, Sundar L, Chockalingam N, Ramachandran A. Differences in the mechanical characteristics of plantar soft tissue between ulcerated and non-ulcerated foot. J Diabetes Complications. 2016 Sep-Oct;30(7):1293-9. doi: 10.1016/j.jdiacomp — View Citation

Naemi R, Chatzistergos P, Suresh S, Sundar L, Chockalingam N, Ramachandran A. Can plantar soft tissue mechanics enhance prognosis of diabetic foot ulcer? Diabetes Res Clin Pract. 2017 Apr;126:182-191. doi: 10.1016/j.diabres.2017.02.002. Epub 2017 Feb 10. — View Citation

Naemi R, Chatzistergos PE, Chockalingam N. A mathematical method for quantifying in vivo mechanical behaviour of heel pad under dynamic load. Med Biol Eng Comput. 2016 Mar;54(2-3):341-50. doi: 10.1007/s11517-015-1316-5. Epub 2015 Jun 5. — View Citation

NAEMI, R., HEALY, A., Sundar, L., Ramachandran, A.R. and CHOCKALINGAM, N., 2013. A Combined Technique for Randomisation of a Small Number of Participants with a Variety of Covariates into Treatment and Control Groups in Randomised Controlled Trials. Journal of Clinical Trials, 4(01).

Naemi, R., Linyard-Tough, K., Healy, A. and Chockalingam, N., 2015. The influence of slow recovery insole on plantar pressure and contact area during walking. Journal of Mechanics in Medicine and Biology, 15(02), p.1540005.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vibration Perception Threshold	Average of left and right (8 measurement areas per foot)	Up to 6 months
Primary	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	Ankle Strength Left 1	Strength during dorsi flexion using Citec Dynamometer	Up to 6 months
Secondary	Ankle Strength Left 2	Strength during plantar flexion using Citec Dynamometer	Up to 6 months
Secondary	Ankle Strength Right 1	Strength during dorsi flexion using Citec Dynamometer	Up to 6 months
Secondary	Ankle Strength Right 2	Strength during plantar flexion using Citec Dynamometer	Up to 6 months

External Links

•   DiaBSmart