Status:
COMPLETED
Development and Testing of a New Generation of Diabetic Footwear
Lead Sponsor:
Staffordshire University
Collaborating Sponsors:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Conditions:
Diabetes Complications
Diabetic Neuropathies
Eligibility:
All Genders
18-80 years
Phase:
NA
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 deve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01816906
Start Date
April 1 2012
End Date
April 1 2014
Last Update
June 14 2019
Active Locations (1)
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1
IDRF/ AR Hopsitals
Chennai, Tamil Nadu, India, 600008