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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.
Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.
Istituto Ortopedico Rizzoli
Bologna, BO, Italy
RECRUITINGBiological biochemical analysis
Parameters related to the profile of blood biomarkers for inflammation will be acquired from samples collected for Population 1 and Population 2.
Time frame: baseline, 12 months
Clinical - metabolical analysis
These evaluations will include the analysis of patients' medical history
Time frame: baseline, 12 months
Functional analysis
Instrumental evaluations are collected from only Population 1
Time frame: baseline, 12 months
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