Diabetes MellitusDiaFootSuPNCT06760416
Online Diabetic Foot Support Program- Care Kit
A study testing Nursing Education in people with Diabetes Mellitus and Diabetic Foot Ulcer, run by Merve GÃnbaAY at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to examine the effects of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who have previously had a diabetic foot ulcer on diabetic foot outcomes (diabetic foot knowledge level, foot care behavior level, foot care self-efficacy level… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Foot Ulcer, Diabetic Foot
- What is being tested?
- Nursing Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older, Individuals diagnosed with type 2 diabetes, Patients who have had diabetic foot ulcers and have healed, Can read and write Turkish, No visual, hearing, perception and any physical disability, Physical, mental and cognitive competence to participate in self-care activities, Able to use technological products (able to use computers, tablets and smartphones), Individuals who voluntarily agree to participate in the study will constitute the sample
Who cannot join
- Patients with active diabetic foot ulcers, Individuals who cannot read or write, Individuals who cannot use technological devices, Individuals who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Online Diabetic Foot Support Program (DiaFootSuP) and Care Kit on Diabetic Foot Care Outcomes: Randomized Controlled Trial
The aim of this project is to examine the effects of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who have previously had a diabetic foot ulcer on diabetic foot outcomes (diabetic foot knowledge level, foot care behavior level, foot care self-efficacy level, HbA1c, etc.).
Read the detailed description
It was planned as a randomized controlled study to determine the effect of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who had previously had diabetic foot ulcers on diabetic foot outcomes. The sample calculation of the study was based on determining the difference between two independent groups and the sample size for the experimental and control groups was taken as experimental: 31-control: 31 people using the G*Power 3.1.9.6 program. The experimental group was given a foot care kit developed by the researcher, which included special foot care products. Pre-test data for the experimental and control groups are collected from the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Online diabetic foot care training consisting of 5 modules is given individually to the patients in the experimental group. After the training, motivational messages and informative videos are sent once a week for 3 months. Patients are also asked to send photos while doing foot care. The post-test data of the experimental and control groups will be collected at the end of 3 months with the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Training videos will be delivered to the control group at the end of the study.
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer, Diabetic Foot
- Being tested
- Nursing Education
- Keywords
- Diabetic Foot, Type 2 Diabetes, Nursing Education, Foot
- Medical subject headings
- Diabetes Mellitus, 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.
Nursing EducationOther
5 modules of online foot care training, motivational messages and informative videos for the patient who was given a foot care kit
| Study group | Role | What they receive |
|---|---|---|
| Experimental Groups | Experimental | 5 modules of online foot care training, motivational messages and informative videos for the patient who was given a foot care kit Receives: Other: Nursing Education |
| CONTROL GROUP | No intervention | Delivery of training videos after pre-test and post-test application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 5-item Diabetes Foot Care Knowledge Scale
The 5-item Diabetes Foot Care Knowledge Scale, a subscale of the Diabetes Knowledge Questionnaire-24, was used. Cronbach's α value was found to be 0.63. Scores range from 0 to 5, with higher scores indicating higher knowledge levels.
Measured: two week
Foot Self Care Observation Guide
The Cronbach α value of the Foot Self Care Observation Guide was determined as 0.83. The scale consists of 15 items. These items are evaluated as 1=Never, 2=Occasionally, 3=Sometimes, 4=Frequently, 5=Always. The lowest score on the scale is 15, the highest is 75. An increase in the scale score indicates that the individual's self-care behaviors are better.
Measured: two week
Diabetic Foot Care Self Efficacy Scale
Diabetic Foot Care Self Efficacy Scale Cronbach α value was determined as 0.86. The scale consists of nine items. These nine statements are evaluated on an 11-number visual scale, which is stated as "I do not see it as sufficient at all = 0" and "I see it as very sufficient = 10". The lowest score obtained from the scale is 0, the highest score is 90. An increase in the scale score indicates that the individual has high self-efficacy.
Measured: two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Nov 2024
- Primary completion27 Dec 2024
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Model description
- The study is conducted by dividing patients into experimental and control groups using simple randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve GÃnbaAY
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Merve GÃnbaAY, Dokuz Eylul University
- Investigators
- Merve M GÜNBAŞ, Msc. Phd., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760416
- Sponsor's protocol ID
- DokuzEU-IHS-MG-01
- Acronym
- DiaFootSuP
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Online Diabetic Foot Support Program (DiaFootSuP) and Care Kit on Diabetic Foot Care Outcomes: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06760416
- Acronym / sponsor ID
- DiaFootSuP / DokuzEU-IHS-MG-01
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer, Diabetic Foot
- Keywords
- Diabetic Foot, Type 2 Diabetes, Nursing Education, Foot
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Merve GÃnbaAYUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 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.
The aim of this project is to examine the effects of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who have previously had a diabetic foot ulcer on diabetic foot outcomes (diabetic foot knowledge level, foot care behavior level, foot care self-efficacy level, HbA1c, etc.).
Detailed description
It was planned as a randomized controlled study to determine the effect of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who had previously had diabetic foot ulcers on diabetic foot outcomes. The sample calculation of the study was based on determining the difference between two independent groups and the sample size for the experimental and control groups was taken as experimental: 31-control: 31 people using the G*Power 3.1.9.6 program. The experimental group was given a foot care kit developed by the researcher, which included special foot care products. Pre-test data for the experimental and control groups are collected from the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Online diabetic foot care training consisting of 5 modules is given individually to the patients in the experimental group. After the training, motivational messages and informative videos are sent once a week for 3 months. Patients are also asked to send photos while doing foot care. The post-test data of the experimental and control groups will be collected at the end of 3 months with the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Training videos will be delivered to the control group at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is conducted by dividing patients into experimental and control groups using simple randomization.
| Arm | Type | Receives |
|---|---|---|
| Experimental Groups | Experimental | Other: Nursing Education5 modules of online foot care training, motivational messages and informative videos for the patient who was given a foot care kit |
| CONTROL GROUP | No intervention | –Delivery of training videos after pre-test and post-test application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older, Individuals diagnosed with type 2 diabetes, Patients who have had diabetic foot ulcers and have healed, Can read and write Turkish, No visual, hearing, perception and any physical disability, Physical, mental and cognitive competence to participate in self-care activities, Able to use technological products (able to use computers, tablets and smartphones), Individuals who voluntarily agree to participate in the study will constitute the sample
Key exclusion criteria (1 listed)
- Patients with active diabetic foot ulcers, Individuals who cannot read or write, Individuals who cannot use technological devices, Individuals who do not want to participate in the study
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 |
|---|---|---|
| Nursing Education5 modules of online foot care training, motivational messages and informative videos for the patient who was given a foot care kit | Other | Experimental Groups |
Primary outcome
The 5-item Diabetes Foot Care Knowledge Scale
Time frame: two week
The 5-item Diabetes Foot Care Knowledge Scale, a subscale of the Diabetes Knowledge Questionnaire-24, was used. Cronbach's α value was found to be 0.63. Scores range from 0 to 5, with higher scores indicating higher knowledge levels.
Foot Self Care Observation Guide
Time frame: two week
The Cronbach α value of the Foot Self Care Observation Guide was determined as 0.83. The scale consists of 15 items. These items are evaluated as 1=Never, 2=Occasionally, 3=Sometimes, 4=Frequently, 5=Always. The lowest score on the scale is 15, the highest is 75. An increase in the scale score indicates that the individual's self-care behaviors are better.
Diabetic Foot Care Self Efficacy Scale
Time frame: two week
Diabetic Foot Care Self Efficacy Scale Cronbach α value was determined as 0.86. The scale consists of nine items. These nine statements are evaluated on an 11-number visual scale, which is stated as "I do not see it as sufficient at all = 0" and "I see it as very sufficient = 10". The lowest score obtained from the scale is 0, the highest score is 90. An increase in the scale score indicates that the individual has high self-efficacy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- 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.
Merve M GÜNBAŞ, Msc. Phd. principal investigator
Dokuz Eylul 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 Nursing Education in people with Diabetes Mellitus and Diabetic Foot Ulcer, run by Merve GÃnbaAY 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 1 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: under way, not looking for participants, as of the sponsor's last update on 6 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?
This study is still under way. Results are not available in the source record yet.
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?
The 5-item Diabetes Foot Care Knowledge Scale (time frame: two week). 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?
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 6 Jan 2025.