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

RECRUITINGN/ASponsored by Istituto Ortopedico Rizzoli
Actively Recruiting
PhaseN/A
SponsorIstituto Ortopedico Rizzoli
Started2025-11-03
Est. completion2027-03-15
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07021222

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

Conditions2

DiabetesDiabetes Mellitus Foot Ulcer

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