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

Universidad Complutense de Madrid

Status: Completed

Conditions: Diabetes Complications; Diabetes Education; Diabetes Foot Care

Treatments: Behavioral: Structured education intervention; Other: Standard podiatry care

Study type: Interventional

Funder types: Other

Identifiers

NCT07329491

24/742-EC_X

Details and patient eligibility

About

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.

Full description

This randomized clinical trial evaluated the impact of a structured educational intervention on ulcer incidence, patient knowledge, self-care practices, and quality of life in individuals with diabetic foot syndrome (DFS). A total of 42 patients were assigned either to an intervention group-which received two monthly educational sessions delivered by a specialist-or to a control group receiving standard care.

The intervention followed IWGDF recommendations and covered topics such as DFS pathophysiology, glycemic control, ulcer risk identification, and evidence-based preventive strategies. Knowledge was assessed at four time points using a validated questionnaire. Self-care practices were assessed through clinical observation, and skin condition through the CERLCP scale. A qualitative analysis using focus groups explored patients' subjective experiences.

No new foot ulcers developed during the six-month follow-up. The intervention group demonstrated significant improvements in knowledge after the first session, with stable retention between sessions and cumulative gains by the end of the program. Marked improvements were also observed in self-care behaviors, particularly appropriate footwear and socks, nail-cutting technique, and reduction of hyperkeratosis. Skin quality improved with clinically meaningful effect sizes.

The qualitative findings showed that diabetes and DFS substantially affect patients' physical, emotional, social, and economic well-being. The educational intervention enhanced peer support, sense of control, and adherence to preventive self-care.

This study demonstrates that a structured educational intervention-even a single session-can produce rapid and meaningful improvements in knowledge and self-care practices. Larger studies with longer follow-up are required to determine its effectiveness in reducing ulcer incidence over time.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥18 years old) with a confirmed diagnosis of diabetes mellitus (Type

  1 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

42 participants in 2 patient groups

Structured diabetic foot education program

Experimental group

Description:

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.

Treatment:

Behavioral: Structured education intervention

Standard podiatry care without structured education

Active Comparator group

Description:

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

Treatment:

Other: Standard podiatry care