Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Footwear: MCP

+ Footwear :PU

Device
Who is being recruted

Diabetes Mellitus+4

+ Endocrine System Diseases

+ Nervous System Diseases

From 18 to 80 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorStaffordshire University
Last updated: June 14, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01816906
Principal SponsorStaffordshire University
Last updated: June 14, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

82 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesNervous System DiseasesNeuromuscular DiseasesPeripheral Nervous System DiseasesDiabetic NeuropathiesDiabetes Complications

Criteria

7 inclusion criteria required to participate
Ability to walk independently for 10 m

At least one palpable pedal pulse on each foot

Diagnosed with Diabetes by WHO criteria

Lack of sensation to 10 g monofilament or VPT > 25 V

Show More Criteria

7 exclusion criteria prevent from participating
Active foot infection

Alzheimer and dementia and impaired cognitive function

Chronic Kidney Disease

Gross abnormality or Foot deformity requiring footbed customisation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

IDRF/ AR Hopsitals

Chennai, IndiaOpen IDRF/ AR Hopsitals in Google Maps
CompletedOne Study Center