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

Azienda Ospedaliero-Universitaria Careggi

Status: Terminated

Conditions: Diabetic Foot

Treatments: Behavioral: Repeated intervention; Behavioral: Single session

Study type: Interventional

Funder types: Other

Identifiers

NCT03555656

PIEDE2

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Repeated educational intervention

Experimental group

Description:

Repetition every 6 months of a group educational session

Treatment:

Behavioral: Repeated intervention

Control group

Active Comparator group

Description:

Initial single group educational session, with no repetition

Treatment:

Behavioral: Single session