The cost-effectiveness and cost-utility of monitoring foot temperature at home to prevent foot ulcer recurrence in patients with diabetes

INTERVENTION: The intervention consists of usual care added with at‐home daily measurement of foot temperature at 6 predefined locations on both feet + max 1 or 2 locations based on ulcer history or pre‐ulcer status, if different than predefined locations. If foot temperature is abnormal (i.e. >2.2 degrees celcius between same locations on both feet) on 2 consecutive days, the patient is instructed to contact the podiatrist, possibly for further foot diagnosis, and to reduce ambulatory activity until temperatures are normalized. Usual care consists of: once every 1‐3 months foot screening and/or foot care by a fot care specialist, patient education, and, if indicated, therapeutic footwear CONDITION: Diabetes Mellitus, diabetic ulcer, Diabetic foot ; ; PRIMARY OUTCOME: ‐ The proportion of patients with a foot ulcer recurrence on the plantar foot or medial and lateral forefoot surface during 18 months follow‐up ; ; ‐ Cost (savings) per patient without a recurrent foot ulcer and per quality adjusted life year; SECONDARY OUTCOME: ‐ Costs of advanced therapy and ulcer treatment ; ; ‐ Adherence to at‐home temperature monitoring ; ; ‐ In‐shoe dynamic plantar pressure ; ; ‐ Barefoot dynamic plantar pressure ; ; ‐ Number of steps per day (daily ambulatory activity level) ; ; ‐ Footwear use ; ; ‐ Adverse events ; ; ‐ Quality of life INCLUSION CRITERIA: 1. Diabetes mellitus type 1 or 2; 2. Age 18 or above; 3. Loss of protective sensation based on the presence of peripheral neuropathy; 4. Recent history of a foot ulcer or foot amputation (preceding 2 years) 5. Ability to provide informed consent 6. Ambulatory status