Diabetic foot diabetic neuropathy
Conditions
Interventions
the intervention is usual care added with at-home daily measurement of foot
temperatures at 6 predefined locations on both feet. If foot temperature is
increased on 2 consecutive days, the patient i
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus; 2. Age 18 or above; 3. Peripheral neuropathy; 4. Recent history of a foot ulcer or foot amputation, i.e. an ulcer has been present for at least 2 weeks and has healed within four years before randomization, or a diagnosis of midfoot or forefoot Charcot neuro-osteoarthropathy; 5. Ability to provide informed consent; 6. Ambulatory status (i.e. not permanently wheel-chair bound). 7. The patient is treated by a podiatrist or is willing to undergo treatment by a podiatrist from the study.
Exclusion criteria
Exclusion criteria: 1. Active foot ulceration or open amputation sites. 2. Active Charcot neuro-osteo arthropathy. 3. Active foot infection, based on criteria of the PEDIS classification. 4. Amputation proximal to the Chopart joint in both feet. 5. Severe illness that would make 18-months survival unlikely, based on the clinical judgment by the physician 6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on the clinical judgment by the physician. This includes the inability to perform temperature measurements, without having a caretaker who can perform the temperature measurements. 7. Current use of home-monitoring of foot temperature. 8. Critical limb ischemia, based on criteria of the PEDIS classification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Costs per patient without a foot ulcer and per quality adjusted life year. - The proportion of patients with a foot ulcer recurrence during 18-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Costs of advanced therapy and ulcer treatment. - Adherence to at-home foot temperature monitoring. - Health-related quality of life. | — |
Countries
Netherlands
Outcome results
None listed