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

NCT ID: NCT03555656

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-07-10

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Repeated educational intervention

Repetition every 6 months of a group educational session

Group Type EXPERIMENTAL

Repeated intervention

Intervention Type BEHAVIORAL

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

Control group

Initial single group educational session, with no repetition

Group Type ACTIVE_COMPARATOR

Single session

Intervention Type BEHAVIORAL

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

Interventions

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Repeated intervention

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

Intervention Type BEHAVIORAL

Single session

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role lead

Responsible Party

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Edoardo Mannucci

Director, Diabetology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diabetologia AOU Careggi

Florence, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PIEDE2

Identifier Type: -

Identifier Source: org_study_id

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