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

NCT07329491 | Completed

• 1 other identifier: 24/742-EC_X
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic foot; diabetic foot ulcer; health education; self care; quality of life

Outcome Measures

Primary Outcomes (1)

• Incidence of new foot ulceration

  Proportion of participants developing a new diabetes-related foot ulcer (yes/no), defined as a full-thickness skin break on the foot. Assessed through clinical examination and medical record review during routine follow-up visits.

  Baseline and 6-month follow-up

Secondary Outcomes (4)

• Knowledge score (6-item questionnaire)

  Baseline, immediately after the first educational session, 30 days later before the second session, and immediately after the second educational session.

• Self-care behaviors (footwear, socks, toenail trimming, orthoses, maceration, hyperkeratosis)

  Baseline at the first educational session and immediately after the second educational session, 30 days later.

• Sking quality. Questionnaire for the Evaluation of Injury Risk and Skin Quality in Diabetic Foot Sindrome (QERSQ).

  Baseline, immediately after the first educational intervention, and immediately after the second educational intervention at 30 days.

• Quality of life related to diabetic foot syndrome (qualitative assessment)

  One assessment 30 days after study initiation, immediately following completion of the second educational intervention.

Study Arms (2)

Structured diabetic foot education program

EXPERIMENTAL

Participants attended two structured, group-based educational sessions on diabetic foot prevention based on IWGDF guidelines, delivered by a specialist, including foot self-care, footwear, and risk identification.

Behavioral: Structured education intervention

Standard podiatry care without structured education

ACTIVE COMPARATOR

Participants received standard care during routine chiropody consultations at a specialised unit, without additional structured educational intervention.

Other: Standard podiatry care

Interventions

Structured education intervention BEHAVIORAL

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.

Structured diabetic foot education program

Standard podiatry care OTHER

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.

Standard podiatry care without structured education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility was determined based on biological sex (male or female), regardless of the participant's gender self-identification.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years old) with a confirmed diagnosis of diabetes mellitus (Type
• or Type 2).
• Classified at any risk level for diabetic foot ulceration according to the IWGDF Foot Risk Classification.
• Able to walk independently and capable of participating in educational activities and evaluations.
• Able to understand study procedures and voluntarily provide written informed consent.
• Willing to attend educational sessions (intervention group) and complete all scheduled assessments.

You may not qualify if:

• Decline to participate or inability to provide written informed consent.
• Presence of cognitive impairment, neurological disorders, or any condition that limits comprehension or adherence to study procedures.
• Severe physical or functional limitations preventing participation in foot assessments or educational sessions.
• Active diabetic foot ulcer or ongoing treatment for an acute foot wound at enrollment.
• Participation in another clinical trial that could interfere with study outcomes.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Facultad de Enfermería, Fisioterapia y Podología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetic Foot; Health Education

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Principal

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

ES (1)