Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT01816906
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01816906
Study Brief:
Protocol Section:
NCT01816906