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| ID | Type | Description | Link |
|---|---|---|---|
| DiaBSmart -2011-IAPP | Other Grant/Funding Number | FP7-PEOPLE-2011-IAPP Grant Agreement Number 285985 |
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| Name | Class |
|---|---|
| India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCP Insole | Active Comparator | The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India. |
|
| PU insole | Active Comparator | The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Footwear :PU | Device | One group of patients will receive "Footwear" with PU insoles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Strength Left 1 | Strength during dorsi flexion using Citec Dynamometer | Up to 6 months |
| Ankle Strength Left 2 | Strength during plantar flexion using Citec Dynamometer |
| Measure | Description | Time Frame |
|---|---|---|
| Vibration Perception Threshold | Average of left and right (8 measurement areas per foot) | Up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nachiappan Chockalingam, PhD | Staffordshire University | Principal Investigator |
| Lakshmi Sundar, MBBS | AR Hospitals/ IDRF | Study Director |
| Roozbeh Naemi, PhD | Staffordshire University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDRF/ AR Hopsitals | Chennai | Tamil Nadu | 600008 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25012640 | Background | 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. | |
| 26044551 | Background |
| Label | URL |
|---|---|
| DiaBSmart | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | MCP Insole | The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India. Footwear: MCP: One group of patients will receive footwear with MCP insoles |
| FG001 | PU Insole | The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm. Footwear :PU: One group of patients will receive "Footwear" with PU insoles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Six Months |
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| |||||||||||||||||||||
| 12 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | MCP Insole | The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India. Footwear: MCP: One group of patients will receive footwear with MCP insoles |
| BG001 | PU Insole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | cm^2 | 6 months |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MCP Insole | The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India. Footwear: MCP: One group of patients will receive footwear with MCP insoles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulceration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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Technical problems with in-shoe plantar pressure measurements lead to unreliable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Nachiappan Chockalingam | Staffordshire University | +44 1782 295853 | n.chockalingam@staffs.ac.uk |
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| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Footwear: MCP |
| Device |
One group of patients will receive footwear with MCP insoles |
|
| Up to 6 months |
| Ankle Strength Right 1 | Strength during dorsi flexion using Citec Dynamometer | Up to 6 months |
| Ankle Strength Right 2 | Strength during plantar flexion using Citec Dynamometer | Up to 6 months |
| 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. |
| 25245020 | 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. |
| 23643441 | 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. |
| 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). |
| 28484892 | Result | 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. |
| 30114460 | 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. |
| 28259007 | 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. |
| 27338509 | 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. |
| 25937545 | 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. |
| 24795257 | 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. |
| 25454742 | 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. |
| 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. |
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The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.
Footwear :PU: One group of patients will receive "Footwear" with PU insoles
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | meters |
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| Weight | Mean | Standard Deviation | Kilogram |
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| Duration of Diabetes | Mean | Standard Deviation | years |
|
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| Secondary | Ankle Strength Left 1 | Strength during dorsi flexion using Citec Dynamometer | Posted | Mean | Standard Deviation | N | Up to 6 months |
|
|
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| Secondary | Ankle Strength Left 2 | Strength during plantar flexion using Citec Dynamometer | Posted | Mean | Standard Deviation | N | Up to 6 months |
|
|
|
| Secondary | Ankle Strength Right 1 | Strength during dorsi flexion using Citec Dynamometer | Posted | Mean | Standard Deviation | N | Up to 6 months |
|
|
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| Secondary | Ankle Strength Right 2 | Strength during plantar flexion using Citec Dynamometer | Posted | Mean | Standard Deviation | N | Up to 6 months |
|
|
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| Other Pre-specified | Vibration Perception Threshold | Average of left and right (8 measurement areas per foot) | Posted | Mean | Standard Deviation | V | Up to 6 months |
|
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| 0 |
| 34 |
| EG001 | PU Insole | The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm. Footwear :PU: One group of patients will receive "Footwear" with PU insoles. | 2 | 35 | 2 | 35 | 0 | 35 |
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| D009422 | Nervous System Diseases |