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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03555656

Enrollment

Registered

2018-06-13

Start date

2018-03-01

Completion date

2019-07-10

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

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.

Interventions

BEHAVIORALRepeated intervention

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

BEHAVIORALSingle session

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of foot ulcers	24 months

Secondary

Measure	Time frame
Incidence of foot ulcers	6 months
incidence of foot ulcers	12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026