Diabetic foot Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged over 18 years, either sex 2. Diabetes mellitus 3. Signs of peripheral polyneuropathy. Polyneuropathy is defined as absence of pressure sensation (10 gram Semmes Weinstein monofilament) and/or absence of the vibration perception sense (128 Hertz tuning fork).
Exclusion criteria
Exclusion criteria: 1. Polyneuropathy not related to diabetes 2. Type 1 diabetes with a duration less than 10 years 3. An active foot ulcer or a healed ulcer in the past year 4. Severe peripheral arterial disease (ankle pressure less than 50 mmHg measured with a hand held Doppler) 5. Foot surgery or peripheral bypass surgery during the past year 6. Rheumatoid disease and renal replacement therapy 7. Patients should not have consulted a podiatrist in the past year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Development of a foot ulcer during the 3-year follow-up period 2. Number of ulcer related procedures in the 3-month period after the first detection of an ulcer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity of the ulcer 2. Healing time 3. Major interventions 4. Hospitalisation days related to ulceration Measured at the onset of ulceration and after 3 month after onset of ulceration. | — |
Countries
Netherlands