Diabetic Foot UlcerNCT07572188
Diabetic Foot Self Care
An observational study of Diabetic Foot Ulcer and Self Care, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The scale, whose validity and reliability were examined in the study, consists of 26 items. The study sample consisted of 202 individuals with diabetes. Data were collected through face-to-face interviews, with approximately 30 minutes allocated to each individual. 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 Ulcer, Self Care, Nursing Care
- What is being tested?
- Self-Care Tool for Diabetic Foot Prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 202 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Dec 2024
- 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: The study sample consisted of 202 individuals with diabetes.
Who may be able to join
- speaking Turkish
- over 18 years old
- Not having a serious psychiatric diagnosis
- Giving written consent to participate in the study
Who cannot join
- severe visual or auditory problems
- who did not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdag Namık Kemal University
Tekirdağ, Suleymanpasa, 59000
About this study
Official title: Validity and Reliability of the Turkish Version of the Self-Care Tool for Diabetic Foot Prevention
The scale, whose validity and reliability were examined in the study, consists of 26 items. The study sample consisted of 202 individuals with diabetes. Data were collected through face-to-face interviews, with approximately 30 minutes allocated to each individual. The study sample included individuals over 18 years of age, diagnosed with diabetes, who spoke, read, and wrote Turkish, and who provided verbal and written consent to participate in the study. Individuals with serious psychiatric diagnoses, cognitive problems that would impede self-expression, and those who wished to withdraw from the study at any stage were excluded from the study sample.
Read the detailed description
The scale, whose validity and reliability were examined in the study, consists of 26 items. The study sample consisted of 202 individuals with diabetes. Data were collected through face-to-face interviews, with approximately 30 minutes allocated to each individual. The study sample included individuals over 18 years of age, diagnosed with diabetes, who spoke, read, and wrote Turkish, and who provided verbal and written consent to participate in the study. Individuals with serious psychiatric diagnoses, cognitive problems that would impede self-expression, and those who wished to withdraw from the study at any stage were excluded from the study sample.
- Conditions
- Diabetic Foot Ulcer, Self Care, Nursing Care
- Being tested
- Self-Care Tool for Diabetic Foot Prevention
- Keywords
- diabetic foot, self care, nursing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care Tool for Diabetic Foot PreventionBehavioural
This study examines the validity and reliability of the Turkish version of the Self-Care Tool for Diabetic Foot Prevention, developed according to the theory of Riegel et al.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care Tool for Diabetic Foot Prevention
This tool consists of 26 items and 3 sub-dimensions, evaluated on a 5-point Likert scale. The sub-dimensions are based on Riegel et al.'s moderate self-care theory. These sub-dimensions are maintaining self-care, monitoring self-care, and managing self-care. The maintaining self-care sub-dimension (10 items) consists of recommendations from healthcare professionals regarding daily foot care and diabetes-related practices to prevent diabetic foot ulcers. The monitoring self-care sub-dimension (9 items) includes behaviors related to monitoring early and initial signs of foot injuries. The managing self-care sub-dimension (7 items) consists of recommendations for practices aimed at eliminating risk factors for foot health.
Measured: 21 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Apr 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla AVCU, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572188
- Sponsor's protocol ID
- Diabetic Foot
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Self-Care Tool for Diabetic Foot Prevention
- ClinicalTrials.gov ID
- NCT07572188
- Acronym / sponsor ID
- Diabetic Foot
- Conditions
- Diabetic Foot Ulcer, Self Care, Nursing Care
- Keywords
- diabetic foot, self care, nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 7 May 2026 (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 scale, whose validity and reliability were examined in the study, consists of 26 items. The study sample consisted of 202 individuals with diabetes. Data were collected through face-to-face interviews, with approximately 30 minutes allocated to each individual. The study sample included individuals over 18 years of age, diagnosed with diabetes, who spoke, read, and wrote Turkish, and who provided verbal and written consent to participate in the study. Individuals with serious psychiatric diagnoses, cognitive problems that would impede self-expression, and those who wished to withdraw from the study at any stage were excluded from the study sample.
Detailed description
The scale, whose validity and reliability were examined in the study, consists of 26 items. The study sample consisted of 202 individuals with diabetes. Data were collected through face-to-face interviews, with approximately 30 minutes allocated to each individual. The study sample included individuals over 18 years of age, diagnosed with diabetes, who spoke, read, and wrote Turkish, and who provided verbal and written consent to participate in the study. Individuals with serious psychiatric diagnoses, cognitive problems that would impede self-expression, and those who wished to withdraw from the study at any stage were excluded from the study sample.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample consisted of 202 individuals with diabetes.
Key inclusion criteria (4 listed)
- speaking Turkish
- over 18 years old
- Not having a serious psychiatric diagnosis
- Giving written consent to participate in the study
Key exclusion criteria (2 listed)
- severe visual or auditory problems
- who did not volunteer 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 |
|---|---|---|
| Self-Care Tool for Diabetic Foot PreventionThis study examines the validity and reliability of the Turkish version of the Self-Care Tool for Diabetic Foot Prevention, developed according to the theory of Riegel et al. | Behavioural | – |
Primary outcome
Self-Care Tool for Diabetic Foot Prevention
Time frame: 21 month
This tool consists of 26 items and 3 sub-dimensions, evaluated on a 5-point Likert scale. The sub-dimensions are based on Riegel et al.'s moderate self-care theory. These sub-dimensions are maintaining self-care, monitoring self-care, and managing self-care. The maintaining self-care sub-dimension (10 items) consists of recommendations from healthcare professionals regarding daily foot care and diabetes-related practices to prevent diabetic foot ulcers. The monitoring self-care sub-dimension (9 items) includes behaviors related to monitoring early and initial signs of foot injuries. The managing self-care sub-dimension (7 items) consists of recommendations for practices aimed at eliminating risk factors for foot health.
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 7 May 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Diabetic Foot Ulcer and Self Care, run by Namik Kemal 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 2 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 7 May 2026. 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?
Self-Care Tool for Diabetic Foot Prevention (time frame: 21 month). 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 7 May 2026.