Foot Ulcer, DiabeticNCT06753799
The Effect of Education on Patient Care Outcomes in Individuals With Diabetic Foot Ulcer
A study testing The intervention group received training based on Social Cognitive Learning Theory. in people with Foot Ulcer, Diabetic and Patient Engagement, run by Fadime Koyuncu at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of Social Cognitive Learning Theory-based education on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic, Patient Engagement, Self Efficacy
- What is being tested?
- The intervention group received training based on Social Cognitive Learning Theory.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2024to 27 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 18 years of age or older Agree to participate in the study Have type 2 diabetes Have a Wagner classification score of 2 Have the same wound care protocols (epidermal growth factor/hyalunoric acid containing cream and dressing with gauze)
Who cannot join
- Having communication difficulties and mental retardation Having vision and manual dexterity problems Having diabetic foot infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gulhane Faculty of Nursing
Ankara, 06010
About this study
Official title: The Effect of Education Based on Social Cognitive Learning Theory on Patient Participation, Self-Efficacy and Wound Healing in Individuals With Diabetic Foot Ulcer
The aim of this study is to determine the effect of Social Cognitive Learning Theory-based education on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers. The research was conducted with 52 patients (25 intervention and 27 control) with Wagner 2 diabetic foot ulcers at Gülhane Training and Research Hospital between January and September 2024.
Read the detailed description
The study was conducted in four stages: first application to the clinic, 1st month, 2nd month and 3rd month. While the Social Cognitive Learning Theory was applied to the intervention group, only the currrent clinical education was provided to the control group. The research data were collected using the "Data Collection Form Regarding Participants' Identifying Characteristics", "Diabetic Foot Information Form", "Metabolic Status and Wound Follow-up Form", "Patient Participation Scale" and "Diabetic Foot Care Self-Efficacy Scale". The results of this study show that education based on Social Cognitive Learning Theory is effective on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers.
- Conditions
- Foot Ulcer, Diabetic, Patient Engagement, Self Efficacy, Wound Healing, Nursing
- Being tested
- The intervention group received training based on Social Cognitive Learning Theory.
- Keywords
- Diabetic foot ulcer, patient participation, self-efficacy, wound healing, nursing
- Medical subject headings
- Diabetic Foot, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention group received training based on Social Cognitive Learning Theory.Behavioural
One of the theories that provides a conceptual framework for the learning and behavior change process is Social Cognitive Learning Theory. Verbal information is commonly provided in the education of individuals with diabetic foot ulcers. The difference of this study from other studies is that an educational booklet, an educational video and a demonstration method with a diabetic foot model are used during the education within the scope of theory-based education.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Active comparator | The intervention group received training based on Social Cognitive Learning Theory Receives: Behavioral: The intervention group received training based on Social Cognitive Learning Theory. |
| The control group | No intervention | The control group received routine clinical training (is in the form of verbal information) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ulcer size
The result obtained by multiplying the length and width measurements of the ulcer with each other expresses the ulcer size in cm2.
Measured: From enrollment to the end of treatment at 3 months
Change in patient participation
It was assessed with the Patient Health Engagement Scale (PHE-s). The PHE-s was developed based on a 4-stage model of patient. Items of the PHE-s: blackout, arousal, adhesion and eudaimonic project. Patients were asked to respond by positioning themselves between one and seven points in relation to their experience.
Measured: From enrollment to the end of treatment at 3 months
Change in self-efficacy
"Participants achieved a response if they scored a self efficacy status of 0 or 10 on a scale ranging from 0 (worst outcome) to 90 (best outcome)."
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start19 Jan 2024
- Primary completion19 Apr 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadime Koyuncu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fadime Koyuncu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Fadime Koyuncu, 2, Study chair, University of Health Sciences Gulhane Faculty of NursingKerim Bora YILMAZ, 3, Study chair, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753799
- Sponsor's protocol ID
- SBUniversitesi2024
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Based on Social Cognitive Learning Theory on Patient Participation, Self-Efficacy and Wound Healing in Individuals With Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06753799
- Acronym / sponsor ID
- SBUniversitesi2024
- Conditions
- Foot Ulcer, Diabetic, Patient Engagement, Self Efficacy, Wound Healing, Nursing
- Keywords
- Diabetic foot ulcer, patient participation, self-efficacy, wound healing, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fadime KoyuncuUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 31 Dec 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.
The aim of this study is to determine the effect of Social Cognitive Learning Theory-based education on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers. The research was conducted with 52 patients (25 intervention and 27 control) with Wagner 2 diabetic foot ulcers at Gülhane Training and Research Hospital between January and September 2024.
Detailed description
The study was conducted in four stages: first application to the clinic, 1st month, 2nd month and 3rd month. While the Social Cognitive Learning Theory was applied to the intervention group, only the currrent clinical education was provided to the control group. The research data were collected using the "Data Collection Form Regarding Participants' Identifying Characteristics", "Diabetic Foot Information Form", "Metabolic Status and Wound Follow-up Form", "Patient Participation Scale" and "Diabetic Foot Care Self-Efficacy Scale". The results of this study show that education based on Social Cognitive Learning Theory is effective on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Active comparator | Behavioral: The intervention group received training based on Social Cognitive Learning Theory.The intervention group received training based on Social Cognitive Learning Theory |
| The control group | No intervention | –The control group received routine clinical training (is in the form of verbal information) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals 18 years of age or older Agree to participate in the study Have type 2 diabetes Have a Wagner classification score of 2 Have the same wound care protocols (epidermal growth factor/hyalunoric acid containing cream and dressing with gauze)
Key exclusion criteria (1 listed)
- Having communication difficulties and mental retardation Having vision and manual dexterity problems Having diabetic foot infection
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 |
|---|---|---|
| The intervention group received training based on Social Cognitive Learning Theory.One of the theories that provides a conceptual framework for the learning and behavior change process is Social Cognitive Learning Theory. Verbal information is commonly provided in the education of individuals with diabetic foot ulcers. The difference of this study from other studies is that an educational booklet, an educational video and a demonstration method with a diabetic foot model are used during the education within the scope of theory-based education. | Behavioural | The intervention group |
Primary outcome
Change in ulcer size
Time frame: From enrollment to the end of treatment at 3 months
The result obtained by multiplying the length and width measurements of the ulcer with each other expresses the ulcer size in cm2.
Change in patient participation
Time frame: From enrollment to the end of treatment at 3 months
It was assessed with the Patient Health Engagement Scale (PHE-s). The PHE-s was developed based on a 4-stage model of patient. Items of the PHE-s: blackout, arousal, adhesion and eudaimonic project. Patients were asked to respond by positioning themselves between one and seven points in relation to their experience.
Change in self-efficacy
Time frame: From enrollment to the end of treatment at 3 months
"Participants achieved a response if they scored a self efficacy status of 0 or 10 on a scale ranging from 0 (worst outcome) to 90 (best outcome)."
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 31 Dec 2024.
- Individual participant dataSharing planned: No. all collected IPD
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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.
Fadime Koyuncu, 2 study chair
University of Health Sciences Gulhane Faculty of Nursing
Kerim Bora YILMAZ, 3 study chair
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention group received training based on Social Cognitive Learning Theory. in people with Foot Ulcer, Diabetic and Patient Engagement, run by Fadime Koyuncu 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: finished, as of the sponsor's last update on 31 Dec 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?
Change in ulcer size (time frame: From enrollment to the end of treatment at 3 months). 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 31 Dec 2024.