Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients

Azienda Ospedaliero-Universitaria Careggi89 enrolled

Overview

Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Diabetic Foot

Interventions

Repeated interventionBEHAVIORAL

Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention

Single sessionBEHAVIORAL

Single 2-h group session educating patients at foot hygiene and ulcer prevention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus * Either diabetic neuropathy or previous foot ulcer Exclusion Criteria: * Arteriopathy of lower limbs, with ABI\<0.8 or needing revascularization

Locations (1)

Diabetologia AOU Careggi

Florence, Italy

Outcomes

Primary Outcomes

Incidence of foot ulcers

Time frame: 24 months

Secondary Outcomes

Incidence of foot ulcers

Time frame: 6 months

incidence of foot ulcers

Time frame: 12 months

Data from ClinicalTrials.gov

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