Development and Testing of a New Generation of Diabetic Footwear

NCT01816906 | Completed Results DMC

• 2 other identifiers: DiaBSmart-01DiaBSmart -2011-IAPP
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Complications; Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ankle Strength Left 1

  Up to 6 months

• Ankle Strength Left 2

  Up to 6 months

• Ankle Strength Right 1

  Up to 6 months

• Ankle Strength Right 2

  Up to 6 months

Other Outcomes (1)

• Vibration Perception Threshold

  Up to 6 months

Study Arms (2)

MCP Insole

ACTIVE COMPARATOR

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

Device: Footwear: MCP

PU insole

ACTIVE COMPARATOR

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

Device: Footwear :PU

Interventions

Footwear :PU DEVICE

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

PU insole

Footwear: MCP DEVICE

One group of patients will receive footwear with MCP insoles

MCP Insole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Staffordshire University: lead
• India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals: collaborator

Study Sites (1)

IDRF/ AR Hopsitals

Chennai, Tamil Nadu, 600008, India

Location

Related Publications (13)

• 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.

  PMID: 25012640 BACKGROUND

• 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.

  PMID: 26044551 BACKGROUND

• 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.

  PMID: 25245020 BACKGROUND

• 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.

  PMID: 23643441 BACKGROUND

• 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).

  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.

  PMID: 28484892 RESULT

• 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.

  PMID: 30114460 RESULT

• 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.

  PMID: 28259007 RESULT

• 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.

  PMID: 27338509 RESULT

• 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.

  PMID: 25937545 RESULT

• 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.

  PMID: 24795257 RESULT

• 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.

  PMID: 25454742 RESULT

• 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.

  RESULT

Related Links

• DiaBSmart

MeSH Terms

Conditions

Diabetes Complications; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Technical problems with in-shoe plantar pressure measurements lead to unreliable data.

Results Point of Contact

• Title: Professor Nachiappan Chockalingam
• Organization: Staffordshire University

n.chockalingam@staffs.ac.uk

+44 1782 295853

Study Officials

• Nachiappan Chockalingam, PhD

  Staffordshire University

  PRINCIPAL INVESTIGATOR

• Lakshmi Sundar, MBBS

  AR Hospitals/ IDRF

  STUDY DIRECTOR

• Roozbeh Naemi, PhD

  Staffordshire University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biomechanics Facility

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 22, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)