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NCT03555656 Clinical Trial

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

Diabetic Foot Clinical Trial

Official title:
Patient Education for the Prevention of Lower Limb Ulcers in Patients With Type 2 Diabetes: Validation of an Educational Intervention Repeated Every Three Months for 2 Years.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03555656
Other study ID # PIEDE2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date July 10, 2019

Study information
Verified date January 2021
Source Azienda Ospedaliero-Universitaria Careggi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 89
Est. completion date July 10, 2019
Est. primary completion date July 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Repeated intervention
Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention
• Single session
Single 2-h group session educating patients at foot hygiene and ulcer prevention

Locations
Country Name City State
Italy Diabetologia AOU Careggi Florence

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of foot ulcers 24 months
Secondary Incidence of foot ulcers 6 months
Secondary incidence of foot ulcers 12 months
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