Diabetic FootNCT06526936
The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot Care Behavior
A study testing Education in people with Diabetic Foot, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jun 2024to 13 Jun 2025
- 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
- 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
Who cannot join
- Not willing to participate in conflict
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Idm Dialysis Center
Beylikduzu, Cumhuriyet Mahallesi
Ülkü yılmaz, PHD, 05346845482, ulkuyilmaz@beykent.edu.tr
ÜLKÜ YILMAZ, 05346845482, ulkuyilmaz@beykent.edu.tr
About this study
Official title: The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot
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.
Read the detailed description
Diabetic foot causes hospitalization, amputation and serious health problems in individuals. This situation also leads to loss of productivity of the individual, negatively affecting mental health and quality of life; It creates a serious economic burden on the family and healthcare system. However, it is stated that the development of 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. The population of the research consists of 64 diabetic hemodialysis patients. The sample consists of individuals who agreed to participate in the study. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. A normal distribution test will be applied to determine whether the research variables have a normal distribution. In case the research variables do not show normal distribution (p<0.05). In the analysis of variables for which the normality assumption is not met, non-parametric analysis methods Mann Whitney U (for comparisons of two groups) and Kruskal Wallis (for comparisons of three or more groups) will be used. Spearman correlation analysis will be performed to determine the relationship between the continuous variables of the research.
- Conditions
- Diabetic Foot
- Being tested
- Education
- Keywords
- Diabetic Foot, Diabetes, Foot Care, Hemodialysis
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Information about diabetic foot care
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Training will be provided on diabetic foot care. Receives: Behavioral: Education |
| Control group | No intervention | Since it is a control group, no application will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Trainings are 15-20 minutes, once a week. 8 weeks in total will be given as.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start13 Jun 2024
- Primary completion13 Jun 2025 (estimated)
- Study completion13 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü YILMAZ, University of Beykent
- Investigators
- ULKU YILMAZ, Principal investigator, Istanbul Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526936
- Sponsor's protocol ID
- US2024
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot
- ClinicalTrials.gov ID
- NCT06526936
- Acronym / sponsor ID
- US2024
- Conditions
- Diabetic Foot
- Keywords
- Diabetic Foot, Diabetes, Foot Care, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 13 Jun 2025 (estimated)
- Study completion
- 13 Jun 2025 (estimated)
- First posted
- 30 Jul 2024 (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 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.
Detailed description
Diabetic foot causes hospitalization, amputation and serious health problems in individuals. This situation also leads to loss of productivity of the individual, negatively affecting mental health and quality of life; It creates a serious economic burden on the family and healthcare system. However, it is stated that the development of 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. The population of the research consists of 64 diabetic hemodialysis patients. The sample consists of individuals who agreed to participate in the study. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. A normal distribution test will be applied to determine whether the research variables have a normal distribution. In case the research variables do not show normal distribution (p<0.05). In the analysis of variables for which the normality assumption is not met, non-parametric analysis methods Mann Whitney U (for comparisons of two groups) and Kruskal Wallis (for comparisons of three or more groups) will be used. Spearman correlation analysis will be performed to determine the relationship between the continuous variables of the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: EducationTraining will be provided on diabetic foot care. |
| Control group | No intervention | –Since it is a control group, no application will be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to participate in conflict
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 |
|---|---|---|
| EducationInformation about diabetic foot care | Behavioural | Experimental group |
Primary outcome
Developing foot care behavior
Time frame: Trainings are 15-20 minutes, once a week. 8 weeks in total will be given as.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- 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.
ULKU YILMAZ principal investigator
Istanbul Beykent University
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 University of Beykent 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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 ULKU yılmaz, PHD (05346845482, ulkyilmz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing foot care behavior (time frame: Trainings are 15-20 minutes, once a week. 8 weeks in total will be given as.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.