- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06768645
The Effectiveness of Diabetic Foot Wound Prevention Training
January 8, 2025 updated by: Berna Dincer, Istanbul Medeniyet University
The Effectiveness of Diabetic Foot Wound Prevention Training Given With Pecha Kucha (20*20) Presentation Technique: A Randomized Controlled
This study aimed to evaluate the impact of diabetic foot care training delivered using the Pecha Kucha (20*20) presentation method on the knowledge, self-efficacy, and behavior levels of patients with Type 2 diabetes.
Conducted between December 10, 2023, and October 7, 2024, this randomized controlled experimental study included 125 diabetic individuals, with 62 in the experimental group and 63 in the control group.
The experimental group received diabetic foot care education using the Pecha Kucha method, while the control group received conventional education.
Data were collected using the Patient Assessment Form, Diabetes Foot Knowledge Questionnaire, Diabetic Foot Care Self-Efficacy Scale, and Foot Self-Care Behavior Scale.
Study Overview
Status
Completed
Detailed Description
This study aimed to evaluate the impact of diabetic foot care training delivered using the Pecha Kucha (20*20) presentation method on the knowledge, self-efficacy, and behavior levels of patients with Type 2 diabetes.
Conducted between December 10, 2023, and October 7, 2024, this randomized controlled experimental study included 125 diabetic individuals, with 62 in the experimental group and 63 in the control group.
The experimental group received diabetic foot care education using the Pecha Kucha method, while the control group received conventional education.
Data were collected using the Patient Assessment Form, Diabetes Foot Knowledge Questionnaire, Diabetic Foot Care Self-Efficacy Scale, and Foot Self-Care Behavior Scale.
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kartal
-
İstanbul, Kartal, Turkey, 34862
- İstanbul
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosis of type 2 diabetes according to the American Diabetes Association (ADA) criteria at least six months before the study
- age 18 years or older, literacy in and ability to speak Turkish,
- absence of communication/mental problems,
- willingness to participate in the study.
Exclusion Criteria:
- presence of advanced retinopathy, violation of inclusion criteria, withdrawal of consent by the patient.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pecha Kucha
Given Pecha Kucha education
|
The study commenced after obtaining ethical approval and written consent from the relevant institution.
The Pecha Kucha presentation was prepared by the researcher, adhering to established literature and the specific requirements of the technique.
The education covered six key topics: 1) Diabetes and Foot Problems, 2) Daily Foot Care, 3) Appropriate Socks, 4) Appropriate Footwear, 5) Nail Care, and 6) Daily Life Precautions.
Expert opinions were sought from four academics (S.Ö; K.L; Z.Z; G.F) with expertise in the field to establish content validity for the final version of the Pecha Kucha diabetic foot care presentation.
Following expert approval, a pilot study was conducted with 10 diabetic patients who met the sample group criteria.
Feedback from these patients regarding system functionality, clarity, and flow was incorporated to finalize the presentation.
Afterward, the finalized "Pecha Kucha Information" training was delivered to the experimental group.
The presentations were cond
|
|
Active Comparator: Control
normal education
|
traditional diabetic foot care education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Foot Knowledge Questionnaire
Time Frame: up to 24 weeks
|
Diabetes Foot Knowledge Questionnaire min:0 max: 5 , Above average placement
|
up to 24 weeks
|
|
Diabetic Foot Care Self-Efficacy Scale
Time Frame: up to 24 weeks
|
Diabetic Foot Care Self-Efficacy Scale min:0 max:100 , scores above the 50 points
|
up to 24 weeks
|
|
Foot Self-Care Behavior Scale
Time Frame: up to 24 weeks
|
Foot Self-Care Behavior Scale min: 10 max :86, scores above the 48 point
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2023
Primary Completion (Actual)
June 23, 2024
Study Completion (Actual)
October 2, 2024
Study Registration Dates
First Submitted
December 29, 2024
First Submitted That Met QC Criteria
January 8, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 8, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer
-
DEBx Medical B.V.Not yet recruitingDiabetic Foot Wounds | Diabetic Foot Ulcer (DFU) | Diabetic Foot Ulcer Treatment
-
StimLabsNot yet recruitingDiabetic Foot | Foot Ulcer | Ulcer Foot | Diabetic Foot Ulcer (DFU)
-
Applied Biologics, LLCSerena GroupRecruitingUlcer | Diabetic Foot Ulcer | Diabetic Foot Ulcers (DFU) | Foot Ulcer ChronicUnited States
-
Applied Biologics, LLCSerenaGroup, Inc.RecruitingDiabetic Foot | Foot Ulcer | Diabetic Foot Ulcer | Ulcer Foot | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | DFUUnited States
-
Başakşehir Çam & Sakura City HospitalRecruitingDiabetic Foot Infection | Diabetic Amputation Foot Wound | Diabetic Foot DiseaseTurkey (Türkiye)
-
PolarityTETemporarily not availableNeuropathic Diabetic Ulcer - Foot | Diabetic Foot Disease | DFU
-
Cairo UniversityNot yet recruitingDiabetic Foot UlcerEgypt
-
Omeza, LLCSygNola, LLCRecruitingDiabetic Foot UlcerUnited States
-
Universidad Autonoma de Nuevo LeonCompleted
-
Libyan Center for Biotechnology ResearchNot yet recruiting
Clinical Trials on Diabetic foot care education delivered using the Pecha Kucha method
-
University of TabukCompletedDiabetes Mellitus, Type 2 | Preventive Care | Self-careSaudi Arabia