Diabetic FootNCT05974592
The Effect of Nurse-Led Diabetic Foot Self-Management Training Program
A study testing Education in people with Diabetic Foot, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Having Type 2 DM for 1 year or more,
- HbA1C level of 7.5% and below,
- Not using insulin therapy,
- Able to use WhatsApp himself or his relatives
- Individuals who volunteer to participate in the research will be included in the research.
Who cannot join
- Pregnant or having a pregnancy plan,
- Mental or cognitive impairment
- Having a diabetic foot diagnosis confirmed by a physician,
- Individuals with advanced complications (retinopathy, nephropathy, peripheral arterial disease, etc.) associated with DM diagnosed by a physician
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
AYŞE ARIKAN DÖNMEZ, PhD, +903123051580 ext. 149, aysearikan8585@gmail.com
EMİNE ÇELİK POLAT, +905315907186, celikemine995@gmail.com
About this study
Official title: The Effect of Nurse-Led Diabetic Foot Self-Management Training Program on Diabetic Foot Knowledge, Foot Care Behavior, and Self-Efficacy Levels in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Study
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.
Read the detailed description
The data to be obtained from the research will be evaluated by transferring them to the IBM SPSS (Statistical Packages for the Social Sciences) Statistics 23 program. Descriptive statistics for continuous variables (mean, standard deviation, median, minimum, maximum), frequency distribution will be used for categorical variables. Differences between categorical variables will be evaluated with Chi-square test and Fisher Exact test, and relations between numerical variables will be evaluated with Spearman Correlation Analysis. The conformity of the data to the normal distribution will be evaluated with the Shapiro Wilk test of normality and Q-Q graphs. Accordingly, if the parametric test assumptions are met, the Significance Test of the Difference Between Two Means in the comparison of independent group differences; If the parametric test assumptions cannot be met, the Mann-Whitney U test will be used. In dependent group comparisons, if parametric test assumptions are met, Analysis of Variance in Repeated Measurements and Significance Test of Difference Between Two Spouses; Friedman Test and Wilcoxon Paired Two Sample Test will be used when parametric test assumptions are not met. A value of p ≤ 0.05 will be considered statistically significant in all analyses.
- Conditions
- Diabetic Foot
- Being tested
- Education
- Keywords
- diabetic foot, Patient Education, Foot Care, Self-Efficacy, Nurse
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Diabetic Foot Self-Management Training Program will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | To the participants in the intervention group; the "Diabetic Foot Self-Management Training Program (DFSMTP)" will be implemented. Printed, visual, and audio training materials will be used within this training program's scope. Training will be held in the Diabetes Education Room in line with the content of DFSMTP prepared by the researcher after determining the appropriate day and time with the participants. Written (training booklet) and visual (computer and PowerPoint presentation) training materials will be used during this training. The printed training booklet will be delivered to the participants at the end of the training. DFSMTP will be held in three sessions on the same day. In order to reinforce the learning of the participants in the intervention group, DFSMTP will also be video recorded with the presentation of the researcher and this recording will be transferred to the DFSMTP YouTube channel to be created by the researcher. Receives: Other: Education |
| Control Group | No intervention | To the participants in the control group; General information about the anatomy and physiology of the pancreas will be explained with the verbal lecture technique. Participants in this group will receive the training only once. Following the completion of the research, the printed training booklet and YouTube channel link information will be shared with the participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic Foot Care Self-Efficacy Scale (DABS)
It is a Likert-type scale developed by Quarles in 2005 in accordance with western culture to determine the self-perception of diabetic patients in performing diabetic foot care activities. Self-efficacy is measured by scoring between 0 and 10. The scale consists of 9 items. The 9 statements that make up the scale are evaluated on the 11-digit visual scale, which is stated as "I'm not sure = 0 and very sure = 10". The lowest score of the scale is 0, and the highest score is 90. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases. The Cronbach's alpha value of the sub-dimensions of the scale was 0.94. The validity and reliability study of the scale in the Turkish population was carried out by Kir Bicer and Enc (2014), and the Cronbach alpha value was found to be 0.86.
Measured: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
Diabetic Foot Knowledge Scale (DABI)
The Turkish validity-reliability study of the scale developed by Alexandra et al.(2001) to evaluate the diabetic foot information of diabetic patients was conducted by Biçer and Enç (2011). The scale consists of 5 items. Diabetic foot knowledge is evaluated using a 5-item DABÖ, a subscale. The Cronbach alpha value of the Turkish version of the scale was 0.58.
Measured: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
Foot Care Behavior Scale (USAS)
There are 16 items in the scale developed by Borges (2007) in line with the criteria of the American Diabetes Association (ADA) in order to improve foot care behaviors in patients with diabetes (51). The Turkish validity and reliability study was conducted by Kır Biçer and Enç (2014), and it was adapted as a 15-item Foot Care Behavior Scale in line with expert opinions. Each item in the scale is rated on a Likert-type scale between 1 (never) and 5 (always do). The lowest score that can be obtained from the scale is 15; the highest score is 75; High scores indicate that foot care behavior is sufficient. The Cronbach's alpha value for the Turkish version of the scale was found to be 0.83 (high reliability).
Measured: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
Secondary outcomes (1)
Diabetic Foot Evaluation Form (DADF)
Physical examination of the foot will be done by the thesis student using the Diabetic Foot Evaluation Form developed by the Diabetes Nursing Association Diabetic Foot Study Group. In this form, the fingertips, foot body and leg heat, humidity, presence of edema; nail cutting, deformity, finger examination, presence of dorsalis pedis and tibialis posterior pulses, foot sensation test, muscle strength, ankle-arm index, deformities and shoes and ulcer evaluation if any.
Measured: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
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 Diabetic FootStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Celik Polat, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974592
- Sponsor's protocol ID
- 145/10
- Status last verified
- Oct 2023
- First submitted
- 26 Jul 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celik Polat E, Arikan Donmez A, Cakal E. A nurse-led self-efficacy-based hybrid diabetic foot self-management education program for individuals with diabetes: a randomized controlled trial. BMC Nurs. 2026 Feb 10;25(1):233. doi: 10.1186/s12912-026-04396-3.
PubMed 41664048
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Led Diabetic Foot Self-Management Training Program on Diabetic Foot Knowledge, Foot Care Behavior, and Self-Efficacy Levels in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05974592
- Acronym / sponsor ID
- 145/10
- Conditions
- Diabetic Foot
- Keywords
- diabetic foot, Patient Education, Foot Care, Self-Efficacy, Nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 3 Aug 2023 (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.
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.
Detailed description
The data to be obtained from the research will be evaluated by transferring them to the IBM SPSS (Statistical Packages for the Social Sciences) Statistics 23 program. Descriptive statistics for continuous variables (mean, standard deviation, median, minimum, maximum), frequency distribution will be used for categorical variables. Differences between categorical variables will be evaluated with Chi-square test and Fisher Exact test, and relations between numerical variables will be evaluated with Spearman Correlation Analysis. The conformity of the data to the normal distribution will be evaluated with the Shapiro Wilk test of normality and Q-Q graphs. Accordingly, if the parametric test assumptions are met, the Significance Test of the Difference Between Two Means in the comparison of independent group differences; If the parametric test assumptions cannot be met, the Mann-Whitney U test will be used. In dependent group comparisons, if parametric test assumptions are met, Analysis of Variance in Repeated Measurements and Significance Test of Difference Between Two Spouses; Friedman Test and Wilcoxon Paired Two Sample Test will be used when parametric test assumptions are not met. A value of p ≤ 0.05 will be considered statistically significant in all analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: EducationTo the participants in the intervention group; the "Diabetic Foot Self-Management Training Program (DFSMTP)" will be implemented. Printed, visual, and audio training materials will be used within this training program's scope. Training will be held in the Diabetes Education Room in line with the content of DFSMTP prepared by the researcher after determining the appropriate day and time with the participants. Written (training booklet) and visual (computer and PowerPoint presentation) training materials will be used during this training. The printed training booklet will be delivered to the participants at the end of the training. DFSMTP will be held in three sessions on the same day. In order to reinforce the learning of the participants in the intervention group, DFSMTP will also be video recorded with the presentation of the researcher and this recording will be transferred to the DFSMTP YouTube channel to be created by the researcher. |
| Control Group | No intervention | –To the participants in the control group; General information about the anatomy and physiology of the pancreas will be explained with the verbal lecture technique. Participants in this group will receive the training only once. Following the completion of the research, the printed training booklet and YouTube channel link information will be shared with the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- Having Type 2 DM for 1 year or more,
- HbA1C level of 7.5% and below,
- Not using insulin therapy,
- Able to use WhatsApp himself or his relatives
Key exclusion criteria (4 listed)
- Pregnant or having a pregnancy plan,
- Mental or cognitive impairment
- Having a diabetic foot diagnosis confirmed by a physician,
- Individuals with advanced complications (retinopathy, nephropathy, peripheral arterial disease, etc.) associated with DM diagnosed by a physician
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 |
|---|---|---|
| EducationDiabetic Foot Self-Management Training Program will be implemented. | Other | Intervention Group |
Primary outcome
Diabetic Foot Care Self-Efficacy Scale (DABS)
Time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
It is a Likert-type scale developed by Quarles in 2005 in accordance with western culture to determine the self-perception of diabetic patients in performing diabetic foot care activities. Self-efficacy is measured by scoring between 0 and 10. The scale consists of 9 items. The 9 statements that make up the scale are evaluated on the 11-digit visual scale, which is stated as "I'm not sure = 0 and very sure = 10". The lowest score of the scale is 0, and the highest score is 90. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases. The Cronbach's alpha value of the sub-dimensions of the scale was 0.94. The validity and reliability study of the scale in the Turkish population was carried out by Kir Bicer and Enc (2014), and the Cronbach alpha value was found to be 0.86.
Diabetic Foot Knowledge Scale (DABI)
Time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
The Turkish validity-reliability study of the scale developed by Alexandra et al.(2001) to evaluate the diabetic foot information of diabetic patients was conducted by Biçer and Enç (2011). The scale consists of 5 items. Diabetic foot knowledge is evaluated using a 5-item DABÖ, a subscale. The Cronbach alpha value of the Turkish version of the scale was 0.58.
Foot Care Behavior Scale (USAS)
Time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
There are 16 items in the scale developed by Borges (2007) in line with the criteria of the American Diabetes Association (ADA) in order to improve foot care behaviors in patients with diabetes (51). The Turkish validity and reliability study was conducted by Kır Biçer and Enç (2014), and it was adapted as a 15-item Foot Care Behavior Scale in line with expert opinions. Each item in the scale is rated on a Likert-type scale between 1 (never) and 5 (always do). The lowest score that can be obtained from the scale is 15; the highest score is 75; High scores indicate that foot care behavior is sufficient. The Cronbach's alpha value for the Turkish version of the scale was found to be 0.83 (high reliability).
1 secondary outcome
Diabetic Foot Evaluation Form (DADF)
Time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 41664048Celik Polat E, Arikan Donmez A, Cakal E. A nurse-led self-efficacy-based hybrid diabetic foot self-management education program for individuals with diabetes: a randomized controlled trial. BMC Nurs. 2026 Feb 10;25(1):233. doi: 10.1186/s12912-026-04396-3.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Diabetic Foot, run by Hacettepe 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Arıkan Dönmez (+903123051580 ext. 149, aysearikan8585@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic Foot Care Self-Efficacy Scale (DABS) (time frame: It will be applied to the participants at baseline, pre- training, as well as at the 1 month and 8 month follow ups.). 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 NCT05974592, 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 12 Oct 2023.