The Effectiveness of Diabetic Foot Wound Prevention Training

NCT ID: NCT06768645

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-30

Study Completion Date

2024-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient Education Diabetic Foot Ulcer PechaKucha Method

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Assuming a power of 80% and an α risk of. 05, a sample size of 120 was determined to be appropriate. Considering the possibility of missing data, the study initially included 65 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 62 participants in the experimental group and 63 in the control group, due to some participants withdrawing.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pecha Kucha

Given Pecha Kucha education

Group Type EXPERIMENTAL

Diabetic foot care education delivered using the Pecha Kucha method

Intervention Type BEHAVIORAL

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

Control

normal education

Group Type ACTIVE_COMPARATOR

traditional diabetic foot care education

Intervention Type BEHAVIORAL

traditional diabetic foot care education

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diabetic foot care education delivered using the Pecha Kucha method

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

Intervention Type BEHAVIORAL

traditional diabetic foot care education

traditional diabetic foot care education

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Berna Dincer

Nursing Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

İstanbul

Istanbul, Kartal, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Dincer B, Kocali C, Elveren T, Demir S, Demir K, Dolu FN, Feyizoglu G. The Effectiveness of Diabetic Foot Wound Prevention Training Given with Pecha Kucha (20*20) Presentation Technique: A Randomized Controlled. Int J Low Extrem Wounds. 2025 Feb 13:15347346251318778. doi: 10.1177/15347346251318778. Online ahead of print.

Reference Type DERIVED
PMID: 39943850 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IstanbulMU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Discharge Education in Diabetic Surgical Patients
NCT06777836 NOT_YET_RECRUITING NA