Development and Testing of a New Generation of Diabetic Footwear

NCT ID: NCT01816906

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-04-30

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.

Conditions

Diabetes Complications; Diabetic Neuropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MCP Insole

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

Group Type: ACTIVE_COMPARATOR

Footwear: MCP

Intervention Type: DEVICE

One group of patients will receive footwear with MCP insoles

PU insole

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

Group Type: ACTIVE_COMPARATOR

Footwear :PU

Intervention Type: DEVICE

One group of patients will receive "Footwear" with PU insoles

Interventions

Footwear :PU

One group of patients will receive "Footwear" with PU insoles

Intervention Type: DEVICE

Footwear: MCP

One group of patients will receive footwear with MCP insoles

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

OTHER

Sponsor Role: collaborator

Staffordshire University

OTHER

Sponsor Role: lead

Responsible Party

Nachiappan Chockalingam

Director, Biomechanics Facility

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nachiappan Chockalingam, PhD

Role: PRINCIPAL_INVESTIGATOR

Staffordshire University

Lakshmi Sundar, MBBS

Role: STUDY_DIRECTOR

AR Hospitals/ IDRF

Roozbeh Naemi, PhD

Role: STUDY_DIRECTOR

Staffordshire University

Locations

IDRF/ AR Hopsitals

Chennai, Tamil Nadu, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 25012640 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26044551 (View on PubMed)

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. doi: 10.2174/1573399810666140918121438.

Reference Type: BACKGROUND

PMID: 25245020 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23643441 (View on PubMed)

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).

Reference Type: BACKGROUND

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 May 9.

Reference Type: RESULT

PMID: 28484892 (View on PubMed)

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.2018.07.038. Epub 2018 Aug 13.

Reference Type: RESULT

PMID: 30114460 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28259007 (View on PubMed)

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.2016.06.003. Epub 2016 Jun 8.

Reference Type: RESULT

PMID: 27338509 (View on PubMed)

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 2015 Apr 27.

Reference Type: RESULT

PMID: 25937545 (View on PubMed)

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;28(4):488-93. doi: 10.1016/j.jdiacomp.2014.03.011. Epub 2014 Mar 22.

Reference Type: RESULT

PMID: 24795257 (View on PubMed)

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 Mar;29(2):282-7. doi: 10.1016/j.jdiacomp.2014.10.007. Epub 2014 Oct 22.

Reference Type: RESULT

PMID: 25454742 (View on PubMed)

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.

Reference Type: RESULT

Related Links

http://www.diabsmart.eu

DiaBSmart

Other Identifiers

DiaBSmart -2011-IAPP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DiaBSmart-01

Identifier Type: -

Identifier Source: org_study_id