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Clinical Trials in Italy / NCT07021222
Recruiting Not applicable

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

NCT07021222 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2025-11-03
Last updated
2026-01-21

Condition(s) studied

Diabetes Mellitus Foot Ulcer

Investigational drug(s) / intervention(s)

Full AnalysisPartial Analysis

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
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 Exclusion Criteria for population 2: * Infections in progress, ongoing neoplasms * Immunosuppressive therapies, and cortisone-based therapy * Pregnancy and lactation * Inability to provide informed consent

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna BO Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07021222 on ClinicalTrials.gov ↗ ← All trials in Italy