Diabetes Mellitus Foot Ulcer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREFull Analysis
Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.
PROCEDUREPartial Analysis
Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.
Sponsors
Istituto Ortopedico Rizzoli
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Maria Cecilia Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
population 1 will be enrolled with no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); population 2 is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological biochemical analysis | baseline, 12 months | Parameters related to the profile of blood biomarkers for inflammation will be acquired from samples collected for Population 1 and Population 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical - metabolical analysis | baseline, 12 months | These evaluations will include the analysis of patients' medical history |
| Functional analysis | baseline, 12 months | Instrumental evaluations are collected from only Population 1 |
Countries
Italy
Contacts
CONTACTLisa Berti, MD
CONTACTAlberto Leardini, DPHIL
Outcome results
None listed