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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Diabetes Mellitus Foot Ulcer

Treatments: Procedure: Partial Analysis; Procedure: Full Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07021222

DARE-DiaFoot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Population 1

Other group

Description:

Patients affected by diabetes mellitus type-2 with no previous history of foot ulceration, but with a moderate ulcerative risk.

Treatment:

Procedure: Full Analysis

Population 2

Other group

Description:

Patients affected by diabetes mellitus type-2: typical adult subjects affected by diabetic foot, who had foot ulcers and thus in risk grade 3. The ulcerative lesions must have been resolved from at least 6 months, so that there is no longer acute inflammatory process in progress at the time of blood sampling.

Treatment:

Procedure: Partial Analysis