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RECRUITINGINTERVENTIONAL

Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaFoot)

Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form Exclusion Criteria for population 2: - Infections in progress, ongoing neoplasms - Immunosuppressive therapies, and cortisone-based therapy - Pregnancy and lactation - Inability to provide willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Full Analysis

Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.

PROCEDURE

Partial Analysis

Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.

Locations (1)

Istituto Ortopedico Rizzoli
Bologna, BO, Italy