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:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00999635
Eligibility Criteria:
Inclusion Criteria:
* diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant),
* diagnosed with diabetic peripheral neuropathy
* palpable or biphasic pulses
* intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer
* able to walk a minimum of 10 metres unaided
* willing to comply with the requirements of the study.
Exclusion Criteria:
* presented with current or recently healed ulceration less than 6 months prior to study enrolment,
* severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non- bespoke footwear,
* history of major bone or joint surgery of the lower limb including major amputation
* unable to comprehend simple instructions and comply with the study protocols and procedures.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00999635
Study Brief:
Protocol Section:
NCT00999635