Evaluation of the Impact of a Structural Educational Intervention on the Prevention of Diabetic Foot Syndrome: A Ramdomized Clinical Trial Using a Mixed Methods Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incidence of new foot ulceration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Structured diabetic foot education program
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.
干预措施: Structured education intervention (Behavioral)
Standard podiatry care without structured education
Participants received standard care during routine chiropody consultations at a specialised unit, without additional structured educational intervention.
干预措施: Standard podiatry care (Other)
结局指标
主要结局
Incidence of new foot ulceration
时间窗: Baseline and 6-month follow-up
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.
次要结局
- 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.)
研究者
María del Sol Tejeda Ramírez
Investigador Principal
Universidad Complutense de Madrid