diabetic foot ulcers. Foot ulceration. A wound on the foot in a person with diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 years or older 2) Diagnosed with diabetes mellitus 3) A plantar diabetic foot ulcer on the forefoot or midfoot for which offloading by total contact softcast or total contact cast is indicated
Exclusion criteria
Exclusion criteria: 1) Inability or unwillingness to provide a written declaration of informed consent. 2) Unable to mobilize weight-bearing 3) moderate or severe diabetic foot infection, as defined by the international working group on the diabetic foot / infectous diseases society of America (IWGDF / IDSA). 4) Moderate or severe limb ischemia, as defined in the Wound, Ischemia, foot Infection (WIfI) classification. 5) The combination of mild limb ischemia and mild infection, defined in accordance with the WIfI classification and IWGDF / IDSA definitions, respectively. 6) Severe foot deformities (e.g. Charcot neuroarthropathy-related deformity, ankle arthrodesis, partial calcanectomy) which lead to increased pressure and friction on the site of the DFU and thereby make adequate TCSO or TCCO impossible, as judged clinically by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak plantar pressure during a minimum of 12 midgait steps with the affected foot | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient comfort, expressed using a visual analoge scale. | — |
Countries
Netherlands
Outcome results
None listed