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

NCT06250049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25631

Last updated 2025-05-28

No results posted yet for this study

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

Interventions

OTHER

Diabetic foot care protocol

Introduction of the diabetic foot care protocol in Primary Care in Salamanca, sensitization, and training of nursing professionals in Health Centers (HC).

OTHER

Group education sessions for patients and/or caregivers

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

Sponsors & Collaborators

  • Sanidad de Castilla y León

    lead OTHER

Principal Investigators

  • Marta Manzano García · Sanidad de Castilla y León

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-10-01
Completion
2023-11-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250049 on ClinicalTrials.gov