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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03555656
Recruitment Status : Terminated (Futility analysis suggested termination)
First Posted : June 13, 2018
Last Update Posted : January 14, 2021
Information provided by (Responsible Party):
Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Behavioral: Repeated intervention Behavioral: Single session Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Repeated educational intervention
Repetition every 6 months of a group educational session
Behavioral: Repeated intervention
Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention

Active Comparator: Control group
Initial single group educational session, with no repetition
Behavioral: Single session
Single 2-h group session educating patients at foot hygiene and ulcer prevention

Primary Outcome Measures :
  1. Incidence of foot ulcers [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Incidence of foot ulcers [ Time Frame: 6 months ]
  2. incidence of foot ulcers [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03555656

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Diabetologia AOU Careggi
Florence, Italy, 50134
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
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Responsible Party: Edoardo Mannucci, Director, Diabetology, Azienda Ospedaliero-Universitaria Careggi Identifier: NCT03555656    
Other Study ID Numbers: PIEDE2
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies