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

NCT ID: NCT06250049

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25631 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-11-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

This group of patients will be attended according to a diabetic foot care protocol implemented in Primary Care in Salamanca. In addition, those patients and/or caregivers will receive group education sessions on Diabetic Foot Care at the Health Centers.

Group Type: EXPERIMENTAL

Diabetic foot care protocol

Intervention Type: OTHER

Introduction of the diabetic foot care protocol in Primary Care in Salamanca, sensitization, and training of nursing professionals in Health Centers (HC).

Group education sessions for patients and/or caregivers

Intervention Type: OTHER

Conducting group education sessions for patients and/or caregivers on Diabetic Foot Care at the Health Centers.

Control Group

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals included in the "Care for individuals with DM" Service of the Primary Care Services Portfolio of SACYL, aged 14 years and older.

Exclusion Criteria

• Change of patient's residence to another Health Area.
• Patient who voluntarily declines to be included.
• Patients with amputation of both lower limbs.
• Patient's decease.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanidad de Castilla y León

OTHER

Sponsor Role: lead

Responsible Party

Marta Manzano Garcia

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Manzano García

Role: PRINCIPAL_INVESTIGATOR

Sanidad de Castilla y León

Locations

Marta Manzano García

Salamanca, , Spain

Countries

Spain

Other Identifiers

GRS/2534/B/22

Identifier Type: -

Identifier Source: org_study_id