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

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ClinicalTrials.gov Identifier: NCT03555656
Recruitment Status : Terminated (Futility analysis suggested termination)
First Posted : June 13, 2018
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi

Tracking Information
First Submitted Date  ICMJE June 1, 2018
First Posted Date  ICMJE June 13, 2018
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
Incidence of foot ulcers [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
  • Incidence of foot ulcers [ Time Frame: 6 months ]
  • incidence of foot ulcers [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diabetic Foot
Intervention  ICMJE
  • Behavioral: Repeated intervention
    Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention
  • Behavioral: Single session
    Single 2-h group session educating patients at foot hygiene and ulcer prevention
Study Arms  ICMJE
  • Experimental: Repeated educational intervention
    Repetition every 6 months of a group educational session
    Intervention: Behavioral: Repeated intervention
  • Active Comparator: Control group
    Initial single group educational session, with no repetition
    Intervention: Behavioral: Single session
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 12, 2021)
89
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2018)
200
Actual Study Completion Date  ICMJE July 10, 2019
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03555656
Other Study ID Numbers  ICMJE PIEDE2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi
Study Sponsor  ICMJE Azienda Ospedaliero-Universitaria Careggi
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliero-Universitaria Careggi
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP