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Completed

NCT Number: NCT06250049

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

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.

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Key information

Conditions

Primary Health Care Cardiovascular Diseases Diabetes Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

14 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marta Manzano García

Salamanca, 37007, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetic foot care protocol

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

Other

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

Primary outcomes

  1. Percentage of individuals with diabetes mellitus who have undergone examination and exploration of both feet

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals with diabetes mellitus who have undergone examination and exploration of both feet.

  2. Number of individuals with diabetes who have undergone foot risk stratification.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals with diabetes who have undergone foot risk stratification.

  3. Number of individuals with diabetes who have received group education related to diabetic foot care.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals with diabetes who have received group education related to diabetic foot care.

  4. Quality of life of individuals with diabetes

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Quality of life of individuals with diabetes pre and post intervention measured through the COOP-WONCA questionnaire. The COOP/WONCA questionnaire was originally developed by a group of primary care physicians at The Darmouth Primary Care Cooperative Information Project (COOP Project), Hanover, New Hampsshire USA. The questionnaire consists of 9 items with a 5-point Likert-type scale. , where higher scores express worse levels of functioning. It was in 1988 when the World Organization of National Colleges, Academies, and Academic Associations of General Practitioners/Family Physicians (WONCA) adopted this instrument.

  5. Number of individuals with diabetes with a nursing care plan established.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals with diabetes with a nursing care plan established.

  6. Number of individuals with diabetes who have received individual education related to diabetic foot care.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals with diabetes who have received individual education related to diabetic foot care.

Secondary outcomes

  1. Number of Primary Care teams where the sensitization and training strategy has been implemented.

    Time frame: Post-intervention (6-month)

    Number of Primary Care teams where the sensitization and training strategy has been implemented.

  2. Satisfaction level of professionals regarding sensitization and training

    Time frame: Post-intervention (6-month)

    Satisfaction level of professionals regarding sensitization and training through an ad hoc questionnaire carried out by the Ministry of Health of the Government of Castilla y León (SACYL) with a Likert-type scale.

  3. Percentage of professionals who have implemented the protocol after training.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Percentage of professionals who have implemented the protocol after training.

  4. Number of individuals detected with at-risk feet.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals detected with at-risk feet.

  5. Number of individuals detected with diabetic foot.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals detected with diabetic foot.

  6. Number of individuals with diabetes with diabetic foot ulcers who have achieved healing (at least one) in the last year.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals with diabetes with diabetic foot ulcers who have achieved healing (at least one) in the last year.

  7. Number of individuals with diabetes who have undergone lower limb amputation (partial or total) in the last year.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of individuals with diabetes who have undergone lower limb amputation (partial or total) in the last year.

  8. Number of diabetic individuals referred to podiatry, vascular surgery, and traumatology and orthopedics.

    Time frame: Pre (baseline period) and Post-intervention (6-month)

    Number of diabetic individuals referred to podiatry, vascular surgery, and traumatology and orthopedics.

Sponsors and collaborators

Lead sponsor

Sanidad de Castilla y León

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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