DiaBSmart: Development and Testing of a New Generation of Diabetic Footwear

• Sponsor: Staffordshire University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01816906
• Collaborator: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals (Other)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Complications; Diabetic Neuropathies	Device: Footwear :PU; Device: Footwear: MCP	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MCP Insole The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.	Device: Footwear: MCP; One group of patients will receive footwear with MCP insoles
Active Comparator: PU insole The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.	Device: Footwear :PU; One group of patients will receive "Footwear" with PU insoles

Outcome Measures

Primary Outcome Measures

1. Postural Sway During Shod Standing [6 months]

   Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds. Area of the center of pressure excursion

Secondary Outcome Measures

1. Ankle Strength Left 1 [Up to 6 months]

   Strength during dorsi flexion using Citec Dynamometer

2. Ankle Strength Left 2 [Up to 6 months]

   Strength during plantar flexion using Citec Dynamometer

3. Ankle Strength Right 1 [Up to 6 months]

   Strength during dorsi flexion using Citec Dynamometer

4. Ankle Strength Right 2 [Up to 6 months]

   Strength during plantar flexion using Citec Dynamometer

Other Outcome Measures

1. Vibration Perception Threshold [Up to 6 months]

   Average of left and right (8 measurement areas per foot)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IDRF/ AR Hopsitals	Chennai	Tamilnadu	India	600008

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Nachiappan Chockalingam, PhD, Staffordshire University
• Study Director: Lakshmi Sundar, MBBS, AR Hospitals/ IDRF
• Study Director: Roozbeh Naemi, PhD, Staffordshire University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• DiaBSmart

Publications

• 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.
• 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.
• 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.
• 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.
• 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).

• Responsible Party: Nachiappan Chockalingam, Director, Biomechanics Facility, Staffordshire University
• ClinicalTrials.gov Identifier: NCT01816906
• Other Study ID Numbers: DiaBSmart-01; DiaBSmart -2011-IAPP
• First Posted: Mar 22, 2013
• Last Update Posted: Jun 14, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Diabetic Neuropathies; Diabetes Complications

Study Results

Participant Flow

Arm/Group Title	MCP Insole	PU Insole
Arm/Group Description	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	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.
Period Title: Six Months
STARTED	41	41
COMPLETED	20	19
NOT COMPLETED	21	22
Period Title: Six Months
STARTED	20	19
COMPLETED	16	14
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	MCP Insole	PU Insole	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	34	35	69
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	26 76.5%	31 88.6%	57 82.6%
>=65 years	8 23.5%	4 11.4%	12 17.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.4 (8.7)	56.1 (7.2)	58.3 (8.2)
Sex: Female, Male (Count of Participants)
Female	16 47.1%	11 31.4%	27 39.1%
Male	18 52.9%	24 68.6%	42 60.9%
Height (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	1.63 (0.09)	1.67 (0.08)	1.65 (0.09)
Weight (Kilogram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram]	73 (11)	77 (13)	75 (12)
Duration of Diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.3 (7.8)	12.2 (6.0)	12.8 (6.9)

Outcome Measures

1. Primary Outcome

Title	Postural Sway During Shod Standing
Description	Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds. Area of the center of pressure excursion
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCP Insole	PU Insole
Arm/Group Description	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	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.
Measure Participants	20	19
Mean (Standard Deviation) [cm^2]	4.3 (2.8)	3.1 (2.7)

2. Secondary Outcome

Title	Ankle Strength Left 1
Description	Strength during dorsi flexion using Citec Dynamometer
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCP Insole	PU Insole
Arm/Group Description	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	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
Measure Participants	20	19
Mean (Standard Deviation) [N]	111 (40)	116 (44)

3. Secondary Outcome

Title	Ankle Strength Left 2
Description	Strength during plantar flexion using Citec Dynamometer
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCP Insole	PU Insole
Arm/Group Description	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	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
Measure Participants	20	19
Mean (Standard Deviation) [N]	135 (47)	140 (52)

4. Secondary Outcome

Title	Ankle Strength Right 1
Description	Strength during dorsi flexion using Citec Dynamometer
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCP Insole	PU Insole
Arm/Group Description	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	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
Measure Participants	20	19
Mean (Standard Deviation) [N]	107 (37)	110 (39)

5. Secondary Outcome

Title	Ankle Strength Right 2
Description	Strength during plantar flexion using Citec Dynamometer
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCP Insole	PU Insole
Arm/Group Description	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	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
Measure Participants	20	19
Mean (Standard Deviation) [N]	132 (45)	141 (47)

6. Other Pre-specified Outcome

Title	Vibration Perception Threshold
Description	Average of left and right (8 measurement areas per foot)
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCP Insole	PU Insole
Arm/Group Description	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	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
Measure Participants	20	19
Mean (Standard Deviation) [V]	53 (19)	65 (19)

Adverse Events

Time Frame	2 years
Arm/Group Title	MCP Insole		PU Insole
Arm/Group Description	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		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.
All Cause Mortality
	MCP Insole		PU Insole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		2/35 (5.7%)
Serious Adverse Events
	MCP Insole		PU Insole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/34 (5.9%)		2/35 (5.7%)
Skin and subcutaneous tissue disorders
Ulceration	2/34 (5.9%)		2/35 (5.7%)
Other (Not Including Serious) Adverse Events
	MCP Insole		PU Insole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.