Diabete Type 2NCT05404178
Turkish Validity-Reliability Study of the Diabetic Foot Self-Care Questionnaire
An observational study of Diabete Type 2 and Diabetic Foot, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the translation, cross-cultural adaptation and psychometric properties of the Diabetic Foot Self-Care Questionnaire in patients with primary Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Diabetic Foot
- What is being tested?
- Type 2 diabetes group
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 10 Dec 2023
- Phase
- Observational
- 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
Study population: Patients with Type 2 Diabetes
Who may be able to join
- be over 18 years old
- Having Type 2 Diabetes and having a diabetic foot ulcer.
- Volunteering to participate in the research.
Who cannot join
- Have a communication problem
- Presence of lower extremity amputation
- Presence of any ulcer other than diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the translation, cross-cultural adaptation and psychometric properties of the Diabetic Foot Self-Care Questionnaire in patients with primary Type 2 Diabetes.
Read the detailed description
This study will be conducted in descriptive type. The population of the research will be patients with diabetic foot in the Endocrinology clinic and polyclinic of the University Hospital. The sample of the study will consist of patients who meet the research criteria and agree to participate in the research. The data collection tools of the study are the patient questionnaire (19 questions), the Diabetic Foot Self-Care Questionnaire (16 questions) and the Foot Care Behavior Scale, by scanning the literature by the researchers.
English Turkish translations will be made before starting the research. Afterwards, expert opinion will be taken for the suitability of the scale items. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language and content validity will be done for the scale form. The scale items will be translated into Turkish and expert opinions will be taken. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language validity and content validity will be done in the study. Explanatory Factor Analysis will be applied for the validity of the questionnaire. Kaiser Meyer Olkin(KMO) Test, which measures the adequacy of sample size as antecedent tests, and Bartlett's Test For Sphericity will be used to test sphericity. Factor Analysis Principal Component Analysis Method will be applied.
- Conditions
- Diabete Type 2, Diabetic Foot
- Being tested
- Type 2 diabetes group
- Keywords
- Diabete Type 2, Diabetic Foot, Validity and reliability
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 2 diabetes groupOther
Also called Assesment
This is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic Foot Self-Care Questionnaire
The Turkish validity and reliability of a scale consisting of 16 questions created to evaluate self-care in patients with diabetic foot has not been determined. The survey is divided into 3 areas. Areas 1 to 6 are self-care areas, Items 7 to 11 are self-management areas, and areas 12 to 16 are self-exploration areas.
Measured: Baseline
Secondary outcomes (1)
Foot Care Behavior Scale
It was created to develop foot self-care behaviors in diabetes. The scale, which is a 5-point Likert type scale, is scored according to agree-disagreement (1= Never, 2= Sometimes, 3= Sometimes, 4= Often, and 5= Always) and consists of 15 items. The lowest score that can be obtained from the scale, which evaluates foot care behavior as a single dimension, is 15 and the highest score is 75. An increase in the scale score indicates that the individual's foot self-care behaviors are better.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start10 Jun 2022
- Primary completion10 Dec 2022
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Caner Di̇ki̇ci̇, Harran University
- Investigators
- İbrahim C Di̇ki̇ci̇, MSc, Study director, Harran UniversityZeynal Yasacı, MSc, Study chair, Harran UniversityDerya Tülüce, PhD, Study chair, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404178
- Sponsor's protocol ID
- 25746723
- Status last verified
- Jan 2024
- First submitted
- 31 May 2022
- Last updated
- 22 Jan 2024
- 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity-Reliability Study of the Diabetic Foot Self-Care Questionnaire
- ClinicalTrials.gov ID
- NCT05404178
- Acronym / sponsor ID
- 25746723
- Conditions
- Diabete Type 2, Diabetic Foot
- Keywords
- Diabete Type 2, Diabetic Foot, Validity and reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 3 Jun 2022 (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 study is to evaluate the translation, cross-cultural adaptation and psychometric properties of the Diabetic Foot Self-Care Questionnaire in patients with primary Type 2 Diabetes.
Detailed description
This study will be conducted in descriptive type. The population of the research will be patients with diabetic foot in the Endocrinology clinic and polyclinic of the University Hospital. The sample of the study will consist of patients who meet the research criteria and agree to participate in the research. The data collection tools of the study are the patient questionnaire (19 questions), the Diabetic Foot Self-Care Questionnaire (16 questions) and the Foot Care Behavior Scale, by scanning the literature by the researchers.
English Turkish translations will be made before starting the research. Afterwards, expert opinion will be taken for the suitability of the scale items. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language and content validity will be done for the scale form. The scale items will be translated into Turkish and expert opinions will be taken. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language validity and content validity will be done in the study. Explanatory Factor Analysis will be applied for the validity of the questionnaire. Kaiser Meyer Olkin(KMO) Test, which measures the adequacy of sample size as antecedent tests, and Bartlett's Test For Sphericity will be used to test sphericity. Factor Analysis Principal Component Analysis Method will be applied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 Diabetes
Key inclusion criteria (3 listed)
- be over 18 years old
- Having Type 2 Diabetes and having a diabetic foot ulcer.
- Volunteering to participate in the research.
Key exclusion criteria (3 listed)
- Have a communication problem
- Presence of lower extremity amputation
- Presence of any ulcer other than diabetes
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 |
|---|---|---|
| Type 2 diabetes groupAlso: AssesmentThis is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist. | Other | – |
Primary outcome
Diabetic Foot Self-Care Questionnaire
Time frame: Baseline
The Turkish validity and reliability of a scale consisting of 16 questions created to evaluate self-care in patients with diabetic foot has not been determined. The survey is divided into 3 areas. Areas 1 to 6 are self-care areas, Items 7 to 11 are self-management areas, and areas 12 to 16 are self-exploration areas.
1 secondary outcome
Foot Care Behavior Scale
Time frame: Baseline
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 22 Jan 2024.
- 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.
İbrahim C Di̇ki̇ci̇, MSc study director
Harran University
Zeynal Yasacı, MSc study chair
Harran University
Derya Tülüce, PhD study chair
Osmaniye Korkut Ata University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2 and Diabetic Foot, run by Harran 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 3 inclusion and 3 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 22 Jan 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?
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?
Diabetic Foot Self-Care Questionnaire (time frame: Baseline). 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 22 Jan 2024.