diabetes, loss of sensation loss of sensation
Conditions
Interventions
The SHOE-OFF protocol: structured, protocolized, quantified, evidence-based, and documentable assistive device care, providing as much offloading as necessary to heal and prevent ulcers, while priorit
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Neuropathy and a ulcer on the plantar side of the foot.
Exclusion criteria
Exclusion criteria: None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life, measured using the EQ-5D-5L and expressed in quality-adjusted life years (QALYs). This outcome measure was chosen because it best captures both clinical effects and the patient perspective, because it is part of the Core Outcome Set for research on diabetic foot ulcers, because the study is conducted in a population where quality of life is significantly reduced when a foot ulcer is present, and because it facilitates comparison with other studies. Hospitals will collect this data as part of standard care at their centers, as part of the PROMs determined in standard care.In addition, the other endpoints from the Core Outcome Set will be collected, as they are all part of routinely recording healthcare outcomes in the patient record: time to healing, foot infection, foot or leg amputation, ulcer recurrence, and mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Costeffectiveness, percentage ulcer healing at 12 and 52 weeks, time to ulcer healing, ulcer recurrence, ulcer-free survival days, physical activity, amputations, infections, mortality, satisfaction with the protocol, adverse events (i.e. falls and pre-ulcer lesions). | — |
Countries
Netherlands
Contacts
Public ContactJ. van Netten
Amsterdam UMC
Outcome results
None listed