NCT01816906|CompletedResultsDMC
Development and Testing of a New Generation of Diabetic Footwear
DiaBSmart
Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · FP7-PEOPLE-2011-IAPP Grant Agreement Number 285985
interventional
82
1 country
1
Study Start
April 2012
Actual (reported)Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)This particular trial is looking to compare the effectiveness of two types of foot bed/ sole materials used within diabetic footwear.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Actual (reported)March 14, 2013
Actual (reported)March 22, 2013
Actual (reported)April 2014
Actual (reported)April 2014
Actual (reported)June 14, 2019
Actual (reported)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
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
Vibration Perception Threshold
Up to 6 months
The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.
The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.
One group of patients will receive "Footwear" with PU insoles
One group of patients will receive footwear with MCP insoles
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
IDRF/ AR Hopsitals
Chennai, Tamil Nadu, 600008, India
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.
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.
Technical problems with in-shoe plantar pressure measurements lead to unreliable data.
Nachiappan Chockalingam, PhD
Staffordshire University
Lakshmi Sundar, MBBS
AR Hospitals/ IDRF
Roozbeh Naemi, PhD
Staffordshire University
82 participants (actual enrollment reported by the registry).
First Submitted
March 14, 2013
First Posted
March 22, 2013
Study Start
April 2012
Actual (reported)Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
Contact the study team to confirm eligibility.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
June 14, 2019
Results First Posted
June 14, 2019
Record last verified: 2019-03
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