NCT05974592

The Effect of Nurse-Led Diabetic Foot Self-Management Training Program

Status unknown NA Last updated 12 October 2023

What this trial tests

NA trial testing Education in Diabetic Foot in 50 participants. Status unknown.

Timeline

1 September 2023

Primary endpoint
30 December 2023

30 January 2024

Quick facts

Lead sponsor	Hacettepe University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	50
Start date	1 September 2023
Primary completion	30 December 2023
Estimated completion	30 January 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Education

Conditions studied

• Diabetic Foot — all drugs for Diabetic Foot →

Sponsor

Hacettepe University

Who can join

18 and older, any sex, with Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetic foot is one of the most important chronic complications of Diabetes Mellitus (DM), which is a global health problem today. Diabetic foot not only affects the individual's quality of life, body image, role performance, and social and economic structure of the family and society but also creates a serious burden on the individual's family and health system. Therefore, some approaches that include foot and nail care, shoe and sock(s) selection, nutrition, and exercise practices are recommended to prevent diabetic foot and to increase functional capacity, without the need for surgical treatment. It is crucial to maintain these recommended approaches throughout the patient's life to ensure effective management of the diabetic foot. This study aims to determine the effect of the nurse-led diabetic foot self-management training program on diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2 DM. This study was planned in a randomized controlled design. The population of the study will consist of type 2 DM patients who do not use insulin therapy and who applied to University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital Diabetes outpatient clinic and Diabetes Education outpatient clinic between September 2022 and September 2023. According to the power analysis, 38 participants are targeted to be reached in total. Data will be collected with a Personal Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale, Diabetic Foot Care Self-Efficacy Scale, and Diabetic Foot Evaluation Form. As a result of this study, it is expected that the nurse-led diabetic foot self-management training program will increase the diabetic foot knowledge, foot care behavior and self-efficacy levels of diabetic foot knowledge, foot care behavior, and self-efficacy level in patients with type 2 DM.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A nurse-led self-efficacy-based hybrid diabetic foot self-management education program for individuals with diabetes: a randomized controlled trial.
   Çelik Polat E, Arıkan Dönmez A, Çakal E. · · 2026 · PMID 41664048 · DOI 10.1186/s12912-026-04396-3