Diabetes-related foot ulcer, diabetic foot ulcer (DFU), Charcot neuro-osteoarthropathy (CNO), Charcot foot, diabetic foot complications. Foot wound due to diabetes, Charcot foot (a diabetes complication where the foot becomes deformed), foot problems caused by diabetes.
Conditions
Interventions
Participants will trial four below-knee offloading devices used in diabetic foot care:• Total Contact Cast (TCC) – a clinician-applied, non-removable cast constructed from standard materials (stockine
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosed with type 1 or type 2 diabetesAged 18 years or olderConfirmed loss of protective sensation (LOPS) due to peripheral neuropathyOne of the following clinical presentations: – History of a healed plantar diabetic foot ulcer within the past two years – Inactive CNO confirmed by clinical and imaging criteria, with or without midfoot deformity
Exclusion criteria
Exclusion criteria: Active diabetic foot ulceration at the time of recruitmentActive Charcot neuro-osteoarthropathy (clinical and/or radiological evidence)Severe peripheral arterial disease, defined as ankle-brachial index < 0.75 or toe pressure < 30 mmHgHistory of major foot amputation (proximal to the midfoot)Presence of other neuropathic syndromes or non-diabetes-related musculoskeletal conditions (e.g. stroke-related hemiparesis, spasticity, or structural deformities unrelated to diabetes) that are likely to confound plantar pressure measurementsAny medical or cognitive condition that would limit ability to participate in study procedures safely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is peak plantar pressure (kPa) measured during standardised walking trials. The main study variable is the difference in peak plantar pressure between offloading devices, compared within the same participant. Lower peak plantar pressure indicates greater offloading effectiveness. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include participant-reported comfort, usability, satisfaction, and overall preference for each offloading device. Exploratory analyses will compare peak plantar pressure outcomes between clinical subgroups: participants with a history of healed plantar diabetic foot ulceration, inactive Charcot neuro-osteoarthropathy (CNO) with midfoot deformity, and inactive CNO without deformity. Descriptive baseline characteristics, including demographic and diabetes-related variables, will also be collected to support interpretation of outcomes. | — |
Countries
Netherlands
Contacts
Public ContactVEL Milbourn
Amsterdam UMC
Outcome results
None listed