Back to resultsRepeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients
Primary Purpose
Diabetic Foot
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Repeated intervention
Single session
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Foot
Eligibility Criteria
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
Sites / Locations
- Diabetologia AOU Careggi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Repeated educational intervention
Control group
Arm Description
Repetition every 6 months of a group educational session
Initial single group educational session, with no repetition
Outcomes
Primary Outcome Measures
Incidence of foot ulcers
Secondary Outcome Measures
Incidence of foot ulcers
incidence of foot ulcers
Full Information
NCT ID
NCT03555656
First Posted
June 1, 2018
Last Updated
January 12, 2021
Sponsor
Azienda Ospedaliero-Universitaria Careggi
1. Study Identification
Unique Protocol Identification Number
NCT03555656
Brief Title
Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Futility analysis suggested termination
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Repeated educational intervention
Arm Type
Experimental
Arm Description
Repetition every 6 months of a group educational session
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Initial single group educational session, with no repetition
Intervention Type
Behavioral
Intervention Name(s)
Repeated intervention
Intervention Description
Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention
Intervention Type
Behavioral
Intervention Name(s)
Single session
Intervention Description
Single 2-h group session educating patients at foot hygiene and ulcer prevention
Primary Outcome Measure Information:
Title
Incidence of foot ulcers
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Incidence of foot ulcers
Time Frame
6 months
Title
incidence of foot ulcers
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Diabetologia AOU Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients
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