NCT07021222

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus Foot Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-03-15
• Completion: 2027-05-15
• First posted: 2025-06-13
• Last updated: 2026-01-21

Locations

1 site across 1 country: Italy