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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus Foot Ulcer

• Registration Number: NCT07021222
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-15
• Primary Completion: 2026-07-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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