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
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