NCT06250049

Improvement of Diabetic Foot Care in Salamanca Through the Implementation of Standardized Protocols.

Effectiveness of the Implementation of a Standardized Foot Care Protocol in Individuals With Diabetes in Primary Care in Salamanca

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25,631 (actual)
• Sponsor: Sanidad de Castilla y León · Academic / Other
• Sex: All
• Age: 14 Years – 99 Years
• Healthy volunteers: Accepted

Summary

Introduction: Diabetic foot (DF) is among the most prevalent complications affecting individuals with diabetes. In Salamanca, 25,631 individuals are enrolled in the Diabetes Care Service, with only 3.06% undergoing a foot examination. Objective: To evaluate the effectiveness of implementing a standardized foot care protocol for individuals with diabetes, accompanied by a sensitization and training strategy for nursing professionals. Methodology: Quasi-experimental pre- and post-study with a control group conducted in the Health Centers of Salamanca. Population: Patients included in the Diabetes Care Service (306) (12,458 men and 11,348 women). Measurements: In professionals: number of professionals involved and satisfaction level. In diabetic individuals: Sociodemographic, anthropometric, lifestyle, and clinical variables related to disease control will be measured, along with variables related to protocol implementation (percentage of diabetics who have undergone foot examination, Ankle-Brachial Index (ABI), risk stratification and foot monitoring, percentage of individuals with DF, percentage of individuals with healed DF ulcers, and percentage of individuals who have undergone amputation). Improvement in quality of life will be measured using the COOP-WONCA questionnaire. Expected outcomes: It is anticipated that this study will provide evidence regarding the relationship between protocol implementation and an increase in the detection and care of at-risk feet and DF, as well as an improvement in the quality of life of individuals with diabetes.

Detailed description

The diabetic foot (DF) is a common complication in individuals with DM, significantly increasing morbidity and mortality. Patients with DM face a 10-20 times higher relative risk of lower limb amputation than those without diabetes, primarily due to ulcers or previous injuries associated with neuropathy and peripheral arterial disease, termed DF (WHO, 2020). Short-to-medium-term mortality post-amputation is comparable to, or even higher than, many cancers (Armstrong et al., 2020). Diabetic foot disease (DFD) causes significant patient suffering and imposes a substantial burden on caregivers, healthcare professionals, health services, and society at large (Schaper et al., 2020). Despite its impact, DFD is often underestimated and underdiagnosed, as healthcare professionals perceive its prevalence and clinical, social, and economic consequences inadequately (Suárez and Lozano, 2014). In Spain, DF screening and risk stratification are systematically conducted in Primary Care (PC), but overall data show a low percentage of DF examinations and record-keeping in medical records, with significant variations among autonomous communities, potentially influenced by the implementation of strategies addressing this complication (Ministry of Health, 2022). To address existing barriers hindering more equitable and high-quality care for DF patients within the National Health System (NHS), the document "Diabetic Foot Management" is developed as part of the Diabetes Strategy (Ministry of Health, 2022). Based on the International Working Group on the Diabetic Foot (IWGDF) consensus, it incorporates key recommendations from various guidelines regarding educational aspects (for patients, caregivers, and professionals), DF screening, and interventions to reduce amputations and enhance the quality of life. It emphasizes that DF management should primarily occur in Primary Care, adopting a multidisciplinary approach (Ministry of Health, 2022).

Conditions

• Primary Health Care
• Diabetes
• Diabetic Foot

Interventions

Type	Name	Description
OTHER	Diabetic foot care protocol	Introduction of the diabetic foot care protocol in Primary Care in Salamanca, sensitization, and training of nursing professionals in Health Centers (HC).
OTHER	Group education sessions for patients and/or caregivers	Conducting group education sessions for patients and/or caregivers on Diabetic Foot Care at the Health Centers.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2024-02-08
• Last updated: 2025-05-28

Locations

1 site across 1 country: Spain