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Impact of an Educational Intervention on Ulcer Incidence, Knowledge, Self-Care, and Quality of Life in Diabetic Foot Syndrome

NCT07329491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-12

No results posted yet for this study

Summary

This randomized clinical trial assessed the impact of a structured educational intervention in patients with diabetic foot syndrome. Forty-two participants were allocated to an intervention group-receiving two specialist-led educational sessions-or to a control group with standard care.

The intervention produced significant improvements in knowledge and self-care after the first session, with stable retention and cumulative benefits by the end of the program. Clinically relevant improvements were also observed in skin condition and preventive foot-care behaviors such as appropriate footwear, socks, and nail-cutting technique.

Qualitative data showed that diabetes and DFS strongly affect quality of life, while group-based education enhanced peer support, sense of control, and adherence to preventive care. No ulcers occurred during the six-month follow-up.

Structured educational interventions are effective and rapidly beneficial, though larger studies with longer follow-up are needed to confirm their impact on ulcer prevention.

Conditions

  • Diabetes Complications
  • Diabetes Education
  • Diabetes Foot Care

Interventions

BEHAVIORAL

Structured education intervention

Participants in the intervention arm received a structured educational program delivered face-to-face in small groups by a healthcare professional specialized in diabetic foot prevention. The program comprised two monthly sessions (2 hours each) following IWGDF recommendations. Session topics included diabetic foot pathophysiology, ulcer risk identification, glycaemic control, daily foot inspection, proper footwear and sock selection, nail care, skin care (hydration/creams) and recognition of warning signs. Teaching methods combined short lectures, visual materials, case examples and group discussion; participants received printed take-home guidance. Knowledge, self-care behaviours and foot skin condition were assessed pre/post intervention and participants were followed for 6 months to monitor outcomes. Structured diabetic foot education.

OTHER

Standard podiatry care

Routine podiatry care provided during regular chiropody consultations at a specialised unit, including clinical foot assessment and usual advice, without any structured or formal educational program.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07329491 on ClinicalTrials.gov