This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.

This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.

A first population has no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); a second population is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months.

One centre provides thorough biomechanical and functional analyses also based on modern Computed Tomography in weight-bearing; another centre performs state-of-the-art clinical assessments and metabolic analyses; the third centre performs the latter, together with advanced biological and biochemical analyses.

Comparisons of all these multi-instrumental measurements between the two populations are performed at baseline and at 12 month follow-up, with multidisciplinary investigative approach.

A mix of risk and predisposition factors should emerge combining the three groups of measures, in the two populations, along the two times of data collection.

Inclusion Criteria for population 1:

• Male and female patients aged between 18 and 75 years.
• Diabetes mellitus type-2 patients with mild to moderate risk of ulceration at the foot (grade 2).

Inclusion Criteria for population 2:

• Male and female patients aged between 18 and 75 years.
• Patients with diabetes mellitus type-2 and diabetic foot with an history of ulcerative lesions (grade 3), healed for at least 6 months.

Exclusion Criteria for population 1:

• History or evidence of ulcers at the foot
• Infections in progress, ongoing neoplasms
• Immunosuppressive therapies, and cortisone-based therapy
• Pregnancy and lactation
• Inability to provide informed consent

Exclusion Criteria for population 2:

• Infections in progress, ongoing neoplasms
• Immunosuppressive therapies, and cortisone-based therapy
• Pregnancy and lactation
• Inability to provide informed consent

Data will not be shared until a full collection, analysis and major comprehension of the dataset by the scientists in the three centers involved; this dataset in fact is going to be very vast, very complex, and multi-disciplinary, and also the statistical analysis is expected to be difficult. These activities thus do deserve a careful scrutiny by the designers of the study before the dataset can be managed by other scientists; and this is going to take many years.