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Development and Testing of a New Generation of Diabetic Footwear

Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01816906
Acronym
DiaBSmart
Enrollment
82
Registered
2013-03-22
Start date
2012-04-30
Completion date
2014-04-30
Last updated
2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Complications, Diabetic Neuropathies

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.

Interventions

DEVICEFootwear :PU

One group of patients will receive Footwear with PU insoles

DEVICEFootwear: MCP

One group of patients will receive footwear with MCP insoles

Sponsors

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
CollaboratorOTHER
Staffordshire University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Postural Sway During Shod Standing6 monthsPostural sway was recorded while standing on a pressure mat with eyes open for 30 seconds. Area of the center of pressure excursion

Secondary

MeasureTime frameDescription
Ankle Strength Left 1Up to 6 monthsStrength during dorsi flexion using Citec Dynamometer
Ankle Strength Left 2Up to 6 monthsStrength during plantar flexion using Citec Dynamometer
Ankle Strength Right 1Up to 6 monthsStrength during dorsi flexion using Citec Dynamometer
Ankle Strength Right 2Up to 6 monthsStrength during plantar flexion using Citec Dynamometer

Other

MeasureTime frameDescription
Vibration Perception ThresholdUp to 6 monthsAverage of left and right (8 measurement areas per foot)

Countries

India

Participant flow

Participants by arm

ArmCount
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
34
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
35
Total69

Withdrawals & dropouts

PeriodReasonFG000FG001
12 MonthsAdverse Event22
12 MonthsDeath02
12 MonthsLost to Follow-up21
Six MonthsDid Not Show Up for Baseline Measurement76
Six MonthsLost to Follow-up1416

Baseline characteristics

CharacteristicMCP InsolePU InsoleTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
8 Participants4 Participants12 Participants
Age, Categorical
Between 18 and 65 years
26 Participants31 Participants57 Participants
Age, Continuous60.4 years
STANDARD_DEVIATION 8.7
56.1 years
STANDARD_DEVIATION 7.2
58.3 years
STANDARD_DEVIATION 8.2
Duration of Diabetes13.3 years
STANDARD_DEVIATION 7.8
12.2 years
STANDARD_DEVIATION 6
12.8 years
STANDARD_DEVIATION 6.9
Height1.63 meters
STANDARD_DEVIATION 0.09
1.67 meters
STANDARD_DEVIATION 0.08
1.65 meters
STANDARD_DEVIATION 0.09
Sex: Female, Male
Female
16 Participants11 Participants27 Participants
Sex: Female, Male
Male
18 Participants24 Participants42 Participants
Weight73 Kilogram
STANDARD_DEVIATION 11
77 Kilogram
STANDARD_DEVIATION 13
75 Kilogram
STANDARD_DEVIATION 12

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 342 / 35
other
Total, other adverse events
0 / 340 / 35
serious
Total, serious adverse events
2 / 342 / 35

Outcome results

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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
MCP InsolePostural Sway During Shod Standing4.3 cm^2Standard Deviation 2.8
PU InsolePostural Sway During Shod Standing3.1 cm^2Standard Deviation 2.7
Secondary

Ankle Strength Left 1

Strength during dorsi flexion using Citec Dynamometer

Time frame: Up to 6 months

ArmMeasureValue (MEAN)Dispersion
MCP InsoleAnkle Strength Left 1111 NStandard Deviation 40
PU InsoleAnkle Strength Left 1116 NStandard Deviation 44
Secondary

Ankle Strength Left 2

Strength during plantar flexion using Citec Dynamometer

Time frame: Up to 6 months

ArmMeasureValue (MEAN)Dispersion
MCP InsoleAnkle Strength Left 2135 NStandard Deviation 47
PU InsoleAnkle Strength Left 2140 NStandard Deviation 52
Secondary

Ankle Strength Right 1

Strength during dorsi flexion using Citec Dynamometer

Time frame: Up to 6 months

ArmMeasureValue (MEAN)Dispersion
MCP InsoleAnkle Strength Right 1107 NStandard Deviation 37
PU InsoleAnkle Strength Right 1110 NStandard Deviation 39
Secondary

Ankle Strength Right 2

Strength during plantar flexion using Citec Dynamometer

Time frame: Up to 6 months

ArmMeasureValue (MEAN)Dispersion
MCP InsoleAnkle Strength Right 2132 NStandard Deviation 45
PU InsoleAnkle Strength Right 2141 NStandard Deviation 47
Other Pre-specified

Vibration Perception Threshold

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

Time frame: Up to 6 months

ArmMeasureValue (MEAN)Dispersion
MCP InsoleVibration Perception Threshold53 VStandard Deviation 19
PU InsoleVibration Perception Threshold65 VStandard Deviation 19

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026