Improvement of Diabetic Foot Care in Salamanca Through the Implementation of Standardized Protocols.
Condition: Primary Health Care; Diabetes; Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional

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).
    

Intervention name(s): Diabetic foot care protocol; Group education sessions for patients and/or caregivers
Intervention type(s): Other; Other
Intervention description(s): Introduction of the diabetic foot care protocol in Primary Care in Salamanca, sensitization, and training of nursing professionals in Health Centers (HC).; Conducting group education sessions for patients and/or caregivers on Diabetic Foot Care at the Health Centers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention