RecruitingNot ApplicableNCT07021222

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

150 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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).
  • 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 Criteria9

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

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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.


Locations(1)

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

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NCT07021222