NCT03555656

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

June 1, 2018

Last Update Submit

January 12, 2021

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • Incidence of foot ulcers

    24 months

Secondary Outcomes (2)

  • Incidence of foot ulcers

    6 months

  • incidence of foot ulcers

    12 months

Study Arms (2)

Repeated educational intervention

EXPERIMENTAL

Repetition every 6 months of a group educational session

Behavioral: Repeated intervention

Control group

ACTIVE COMPARATOR

Initial single group educational session, with no repetition

Behavioral: Single session

Interventions

Repeated interventionBEHAVIORAL

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

Repeated educational intervention
Single sessionBEHAVIORAL

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Either diabetic neuropathy or previous foot ulcer

You may not qualify if:

  • Arteriopathy of lower limbs, with ABI\<0.8 or needing revascularization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetologia AOU Careggi

Florence, 50134, Italy

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Diabetology

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 13, 2018

Study Start

March 1, 2018

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)