Diabetic neuropathy Numbness
Conditions
Interventions
All participants will receive two pairs of OS, a standard-OS and an additional OS (e.g., the LEEF-shoe), both provided through usual care channels. At handover, plantar pressure measurements will be p
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Aged 18 years or olderDiabetes mellitus type 1 or 2IWGDF Risk 2 - 3Prescribed with fully custom-made orthopedic footwear (OS type A)Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Severe foot deformitiesActive Charcot’s neuroarthropathyFoot ulcer or open amputation siteSevere illness, based on clinical judgment by the physicianNot able to walk at least 10 meters uninterrupted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two primary outcomes of the study are peak plantar pressure and wearing time, both compared between the standard-OS and LEEF-shoe. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes involve user experience and acceptance, assessed through semi-structured focus groups. | — |
Countries
Netherlands
Contacts
Public ContactJ Hijmans
Universitair Medisch Centrum Groningen
Outcome results
None listed