NCT06526936

Brief Summary

Diabetic foot causes hospitalization, amputation and serious health problems in individuals. This situation also leads to loss of productivity of the individual, negatively. diabetic foot can be reduced by 85% with good foot care, education and a multidisciplinary team approach. Diabetes is observed in the majority of hemodialysis patients. Foot care becomes even more important if you have more than one chronic disease. The aim of this study is; To determine the effect of "Diabetic foot care training" given to diabetic hemodialysis patients on foot care behavior. The study was planned as a randomized controlled experimental study. It was planned for diabetic hemodialysis patients who were treated in a dialysis center with a study permit.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 17, 2024

Last Update Submit

July 24, 2024

Conditions

Keywords

Diabetic FootDiabetesFoot CareHemodialysis

Outcome Measures

Primary Outcomes (1)

  • Developing foot care behavior

    Providing training with diabetic foot care guidance As data collection forms in the research; The Participant Information Form prepared by the researcher and the Foot Care Behavior Scale (FBS) will be used. The lowest score that can be obtained on the scale is 15; The highest score is 75. The Cronbach alpha value of the scale was found to have high reliability as 0.83.

    Trainings are 15-20 minutes, once a week. 8 weeks in total will be given as.

Study Arms (2)

Experimental group

EXPERIMENTAL

Training will be provided on diabetic foot care.

Behavioral: Education

Control group

NO INTERVENTION

Since it is a control group, no application will be made.

Interventions

EducationBEHAVIORAL

Information about diabetic foot care

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Having a diagnosis of diabetes
  • Volunteering to participate in the study
  • Good communication skills and the patient's ability to receive training himself

You may not qualify if:

  • Not willing to participate in conflict

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idm Dialysis Center

Beylikduzu, Cumhuriyet Mahallesi, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • ULKU YILMAZ

    Istanbul Beykent University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ULKU yılmaz, PHD

CONTACT

IDM hemodialysis center

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 30, 2024

Study Start

June 13, 2024

Primary Completion

June 13, 2025

Study Completion

June 13, 2025

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations