Patient EducationNCT06768645
The Effectiveness of Diabetic Foot Wound Prevention Training
A study testing Diabetic foot care education delivered using the Pecha Kucha method and traditional diabetic foot care education in people with Patient Education and Diabetic Foot Ulcer, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Education, Diabetic Foot Ulcer, PechaKucha Method
- What is being tested?
- Diabetic foot care education delivered using the Pecha Kucha method and traditional diabetic foot care education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 2 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- presence of advanced retinopathy, violation of inclusion criteria, withdrawal of consent by the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Education, Diabetic Foot Ulcer, PechaKucha Method
- Being tested
- Diabetic foot care education delivered using the Pecha Kucha method, traditional diabetic foot care education
- Keywords
- Pecha Kucha, Type 2 diabetes, Diabetic Foot, Patient Education
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic foot care education delivered using the Pecha Kucha methodBehavioural
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
traditional diabetic foot care educationBehavioural
traditional diabetic foot care education
| Study group | Role | What they receive |
|---|---|---|
| Pecha Kucha | Experimental | Given Pecha Kucha education Receives: Behavioral: Diabetic foot care education delivered using the Pecha Kucha method |
| Control | Active comparator | normal education Receives: Behavioral: traditional diabetic foot care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Foot Knowledge Questionnaire
Diabetes Foot Knowledge Questionnaire min:0 max: 5 , Above average placement
Measured: up to 24 weeks
Diabetic Foot Care Self-Efficacy Scale
Diabetic Foot Care Self-Efficacy Scale min:0 max:100 , scores above the 50 points
Measured: up to 24 weeks
Foot Self-Care Behavior Scale
Foot Self-Care Behavior Scale min: 10 max :86, scores above the 48 point
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start30 Dec 2023
- Primary completion23 Jun 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dincer, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768645
- Sponsor's protocol ID
- IstanbulMU
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Sep;25(3):960-970. doi: 10.1177/15347346251318778. Epub 2025 Feb 13.
PubMed 39943850
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Diabetic Foot Wound Prevention Training Given With Pecha Kucha (20*20) Presentation Technique: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT06768645
- Acronym / sponsor ID
- IstanbulMU
- Conditions
- Patient Education, Diabetic Foot Ulcer, PechaKucha Method
- Keywords
- Pecha Kucha, Type 2 diabetes, Diabetic Foot, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pecha Kucha | Experimental | Behavioral: Diabetic foot care education delivered using the Pecha Kucha methodGiven Pecha Kucha education |
| Control | Active comparator | Behavioral: traditional diabetic foot care educationnormal education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- presence of advanced retinopathy, violation of inclusion criteria, withdrawal of consent by the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic foot care education delivered using the Pecha Kucha methodThe 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 | Behavioural | Pecha Kucha |
| traditional diabetic foot care educationtraditional diabetic foot care education | Behavioural | Control |
Primary outcome
Diabetes Foot Knowledge Questionnaire
Time frame: up to 24 weeks
Diabetes Foot Knowledge Questionnaire min:0 max: 5 , Above average placement
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 39943850Dincer 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. 2026 Sep;25(3):960-970. doi: 10.1177/15347346251318778. Epub 2025 Feb 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic foot care education delivered using the Pecha Kucha method and traditional diabetic foot care education in people with Patient Education and Diabetic Foot Ulcer, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Foot Knowledge Questionnaire (time frame: up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.