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

S

Sanidad de Castilla y León

Status

Completed

Conditions

Diabetic Foot
Diabetes
Primary Health Care

Treatments

Other: Diabetic foot care protocol
Other: Group education sessions for patients and/or caregivers

Study type

Interventional

Funder types

Other

Identifiers

NCT06250049
GRS/2534/B/22

Details and patient eligibility

About

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.

Full 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).

Enrollment

25,631 patients

Sex

All

Ages

14 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25,631 participants in 2 patient groups

Intervention Group
Experimental group
Description:
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.
Treatment:
Other: Group education sessions for patients and/or caregivers
Other: Diabetic foot care protocol
Control Group
No Intervention group
Description:
Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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