Clinical trial NCT06250049: Improvement of Diabetic Foot Care in Salamanca Through the Implementation of Standardized Protocols.
Official title: Effectiveness of the Implementation of a Standardized Foot Care Protocol in Individuals With Diabetes in Primary Care in Salamanca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Health Care
Diabetes
Diabetic Foot
Lead sponsor: Sanidad de Castilla y León
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 25631
Sex: ALL
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Percentage of individuals with diabetes mellitus who have undergone examination and exploration of both feet
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals with diabetes who have undergone foot risk stratification.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals with diabetes who have received group education related to diabetic foot care.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Quality of life of individuals with diabetes
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals with diabetes with a nursing care plan established.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals with diabetes who have received individual education related to diabetic foot care.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
Secondary outcomes:
measure: Number of Primary Care teams where the sensitization and training strategy has been implemented.
timeFrame: Post-intervention (6-month)
measure: Satisfaction level of professionals regarding sensitization and training
timeFrame: Post-intervention (6-month)
measure: Percentage of professionals who have implemented the protocol after training.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals detected with at-risk feet.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals detected with diabetic foot.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals with diabetes with diabetic foot ulcers who have achieved healing (at least one) in the last year.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of individuals with diabetes who have undergone lower limb amputation (partial or total) in the last year.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
measure: Number of diabetic individuals referred to podiatry, vascular surgery, and traumatology and orthopedics.
timeFrame: Pre (baseline period) and Post-intervention (6-month)
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Marta Manzano García
Study officials:
affiliation: Sanidad de Castilla y León
name: Marta Manzano García
role: PRINCIPAL_INVESTIGATOR
References: