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

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

Tracking Information

• First Submitted Date: June 1, 2018
• First Posted Date: June 13, 2018
• Last Update Posted Date: January 14, 2021
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: July 10, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 1, 2018): Incidence of foot ulcers [ Time Frame: 24 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 1, 2018)

• Incidence of foot ulcers [ Time Frame: 6 months ]
• incidence of foot ulcers [ Time Frame: 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Diabetic Foot

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 12, 2021): 89
• Original Estimated Enrollment (submitted: June 1, 2018): 200
• Actual Study Completion Date: July 10, 2019
• Actual Primary Completion Date: July 10, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT03555656
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi
• Study Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Azienda Ospedaliero-Universitaria Careggi
• Verification Date: January 2021