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

NCT06250049 | Completed

• 1 other identifier: GRS/2534/B/22
• Study Type: interventional
• Target: 25,631
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Health Care; Diabetes; Diabetic Foot

Outcome Measures

Primary Outcomes (6)

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

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

  Pre (baseline period) and Post-intervention (6-month)

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

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

  Pre (baseline period) and Post-intervention (6-month)

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

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

  Pre (baseline period) and Post-intervention (6-month)

• Quality of life of individuals with diabetes

  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.

  Pre (baseline period) and Post-intervention (6-month)

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

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

  Pre (baseline period) and Post-intervention (6-month)

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

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

  Pre (baseline period) and Post-intervention (6-month)

Secondary Outcomes (8)

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

  Post-intervention (6-month)

• Satisfaction level of professionals regarding sensitization and training

  Post-intervention (6-month)

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

  Pre (baseline period) and Post-intervention (6-month)

• Number of individuals detected with at-risk feet.

  Pre (baseline period) and Post-intervention (6-month)

• Number of individuals detected with diabetic foot.

  Pre (baseline period) and Post-intervention (6-month)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

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

Control Group

NO INTERVENTION

Usual care

Interventions

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).

Intervention Group

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.

Intervention Group

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanidad de Castilla y León: lead

Study Sites (1)

Marta Manzano García

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Marta Manzano García

  Sanidad de Castilla y León

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 8, 2024
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)