Diabetic FootNCT06780631
The Effect of Web-Based and Face-to-Face Education Based on the Health Promotion Model on Foot Care Behavior in Individuals With Type 2 Diabetes
A study testing Web-based diabetic foot education based on health promotion model and Face to face diabetic foot education based on health promotion model in people with Diabetic Foot and Diabetes Mellitus Type 2, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Diabetic foot is a complication that develops difficult-to-heal foot wounds, reduces the quality of life of individuals with diabetes, causes loss of productivity, and causes economic burden due to the repetition of the problem and the expenditures made for treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot, Diabetes Mellitus Type 2
- What is being tested?
- Web-based diabetic foot education based on health promotion model and Face to face diabetic foot education based on health promotion model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2024to 30 Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with type 2 diabetes at least 6 months ago according to ADA criteria
- Being between the ages of 18 and 80
- Ability to read and write
- Not having received diabetic foot training before
- No existing foot ulcers
- Using the Internet (from sources such as smartphone, tablet, computer)
Show all 9Show fewer
- Being open to communication and collaboration
- No mental problems
- Volunteering to participate in the study
Who cannot join
- Wants to leave the study
- Foot ulcer development in a diabetic individual during work
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic foot is a complication that develops difficult-to-heal foot wounds, reduces the quality of life of individuals with diabetes, causes loss of productivity, and causes economic burden due to the repetition of the problem and the expenditures made for treatment. Diabetic foot is the most common complication requiring hospitalization and is the most common cause of non-traumatic amputations. However, this complication can be prevented with regular foot examinations, patient education and daily foot care. For this reason, diabetic foot education should be given to all diabetic patients and they should be encouraged to participate in their self-care. However, educating patients once does not provide enough knowledge to manage diabetes throughout life. As the rate of individuals using web-based information increases, it is possible to reach large masses. With web-based training, information obtained from current sources is presented to patients on a single web page, patients can access training regardless of place or time, and continuity in training is ensured. The aim of this randomized controlled experimental study is to determine the effect of web-based and face-to-face education based on the health promotion model on diabetic foot knowledge and foot care behavior in individuals with diabetes.
Read the detailed description
The research will be conducted with individuals with type 2 diabetes who volunteered to participate in the study. As data collection tools, Patient Descriptive Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be used. As a pre-test, data will be collected from all patients at the first interview. Then, web-based training based on the health promotion model will be applied to the individuals in the experimental group 1 and face-to-face training will be applied to the individuals in the experimental group 2. The individuals in the control group will be given routine training applied in the hospital. Reminder messages about foot care will be sent to the patients once a week. After the first application, data from all individuals in experiment group 1, experiment group 2 and control group will be collected again and analyzed in the 1st and 3rd months, and the research will be completed. Power analysis was performed using the G*Power (v3.1.9.2) program to determine the number of samples. The power of the study is expressed as 1-β (β = probability of type II error), and in general, studies must have 80% power. The number of samples was determined as 135 in total, 45 people in each group.
- Conditions
- Diabetic Foot, Diabetes Mellitus Type 2
- Being tested
- Web-based diabetic foot education based on health promotion model, Face to face diabetic foot education based on health promotion model
- Keywords
- Diabetic Foot, Self Care, Health Promotiom Model, Web Based Education, Face to Face Education
- Medical subject headings
- 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.
Web-based diabetic foot education based on health promotion modelOther
The first group can access the training at any time and repeat the training thanks to web-based training.
Face to face diabetic foot education based on health promotion modelOther
Individuals with Type 2 diabetes in the face-to-face training group will receive face-to-face diabetic foot training in line with the training booklet for approximately 45 minutes, one by one.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 (Web-based diabetic foot education applied group) | Experimental | 1. In the first interview, individuals in the web training group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital.
2. After the pre-test, a username and password will be defined for individuals in the web training group so that they can log in to the diabetic foot web training page.
3. Patients will be trained on how to access the diabetic foot web training page, how to access information, and how to use videos.
4. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews. Receives: Other: Web-based diabetic foot education based on health promotion model |
| Group-2 (Face to face diabetic foot education applied group) | Experimental | 1. In the first meeting for individuals in the face-to-face education group; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital.
2. After the pre-test, face-to-face diabetic foot training will be given in accordance with the training booklet for approximately 45 minutes.
3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews. Receives: Other: Face to face diabetic foot education based on health promotion model |
| Group-3 Clinical routine education applied group (control) | No intervention | 1. In the first interview, individuals in the control group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Foot Care Behavior Checklist, Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, individuals in the control group will receive routine training given by the training nurse on duty in the diabetes education unit. Education based on the health promotion model will not be implemented. 3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Foot Knowledge Level
The scale consists of 5 items and has no subdimensions. In the evaluation of the scale, the total score of the correct questions from the answers given as 'yes' or 'no' to the knowledge question constitutes the scale score. The scoring changez as 1 or 0. An increase in the scale score indicates an increase in the level of knowledge of diabetic feet.
Measured: The knowledge level of the patients is measured with the 5-item "Diabetes Foot Knowledge Qustionnare" ; It will be evaluated before the training, in the first month and in the third month after the training.
Foot Care Behavior
The scale consists of 15 items and has no sub-dimensions. These items are evaluated as '1=Never', '2=Occasionally', '3=Sometimes', '4=Often', '5=Always'. The lowest score on the scale is 15 and the highest score is 75. An increase in the scale score indicates that the individual's self-care behaviors are better.
Measured: Patients' foot care behaviors will be questioned with the "Foot Self Care Observation Guide" consisting of 15 items; It will be evaluated before the training, in the first month and in the third month after the training.
Foot Care Self-Efficacy
The scale consists of nine items. These nine statements are evaluated on an 11-number visual scale such as 'I don't see it at all adequate = 0' and 'I consider it very adequate = 10'. The lowest score from the scale is 0 and the highest score is 90. An increase in the scale score indicates that the individual's self-efficacy is high.
Measured: Patients' foot care self-efficacy is evaluated with the "Diabetic Foot Care Self Efficacy" consisting of 9 items; It will be evaluated before the training, in the first month and in the third month after the training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start17 May 2024
- Primary completion30 Oct 2024
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Model description
- It is a prospective intervention type three-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as web-based diabetic foot training, Group-2 (Experiment) was designed s face-to-face diabetic foot training, and Group-3 (Control) was designed as clinical routine training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Kürkçü, Marmara University
- Investigators
- Aysun Kürkçü, Principal investigator, Kartal Dr.Lütfi Kırdar City Hospital İstanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780631
- Sponsor's protocol ID
- 09.2023.240
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahin S, Cingil D. Evaluation of the relationship among foot wound risk, foot self-care behaviors, and illness acceptance in patients with type 2 diabetes mellitus. Prim Care Diabetes. 2020 Oct;14(5):469-475. doi: 10.1016/j.pcd.2020.02.005. Epub 2020 Feb 27.
PubMed 32115378Pourkazemi A, Ghanbari A, Khojamli M, Balo H, Hemmati H, Jafaryparvar Z, Motamed B. Diabetic foot care: knowledge and practice. BMC Endocr Disord. 2020 Mar 20;20(1):40. doi: 10.1186/s12902-020-0512-y.
PubMed 32192488Kilic M, Karadag A. Developing and Evaluating a Mobile Foot Care Application for Persons With Diabetes Mellitus: A Randomized Pilot Study. Wound Manag Prev. 2020 Oct;66(10):29-40.
PubMed 33048829Chau JP, Chung LC, Wong RY, Loo KM, Lo SH, So TT, Lau MS, Yeung TH, Leung BS, Tong ML, Li CY, Kwok WW, Thompson DR, Lee DT. An evaluation of a web-based diabetes education program designed to enhance self-management among patients living with diabetes. Comput Inform Nurs. 2012 Dec;30(12):672-9. doi: 10.1097/NXN.0b013e318261f1d2.
PubMed 22872044Abrar EA, Yusuf S, Sjattar EL, Rachmawaty R. Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Prim Care Diabetes. 2020 Apr;14(2):104-110. doi: 10.1016/j.pcd.2019.06.005. Epub 2019 Jul 13.
PubMed 31311727
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based and Face-to-Face Education Based on the Health Promotion Model on Foot Care Behavior in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06780631
- Acronym / sponsor ID
- 09.2023.240
- Conditions
- Diabetic Foot, Diabetes Mellitus Type 2
- Keywords
- Diabetic Foot, Self Care, Health Promotiom Model, Web Based Education, Face to Face Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 17 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.
Diabetic foot is a complication that develops difficult-to-heal foot wounds, reduces the quality of life of individuals with diabetes, causes loss of productivity, and causes economic burden due to the repetition of the problem and the expenditures made for treatment. Diabetic foot is the most common complication requiring hospitalization and is the most common cause of non-traumatic amputations. However, this complication can be prevented with regular foot examinations, patient education and daily foot care. For this reason, diabetic foot education should be given to all diabetic patients and they should be encouraged to participate in their self-care. However, educating patients once does not provide enough knowledge to manage diabetes throughout life. As the rate of individuals using web-based information increases, it is possible to reach large masses. With web-based training, information obtained from current sources is presented to patients on a single web page, patients can access training regardless of place or time, and continuity in training is ensured. The aim of this randomized controlled experimental study is to determine the effect of web-based and face-to-face education based on the health promotion model on diabetic foot knowledge and foot care behavior in individuals with diabetes.
Detailed description
The research will be conducted with individuals with type 2 diabetes who volunteered to participate in the study. As data collection tools, Patient Descriptive Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be used. As a pre-test, data will be collected from all patients at the first interview. Then, web-based training based on the health promotion model will be applied to the individuals in the experimental group 1 and face-to-face training will be applied to the individuals in the experimental group 2. The individuals in the control group will be given routine training applied in the hospital. Reminder messages about foot care will be sent to the patients once a week. After the first application, data from all individuals in experiment group 1, experiment group 2 and control group will be collected again and analyzed in the 1st and 3rd months, and the research will be completed. Power analysis was performed using the G*Power (v3.1.9.2) program to determine the number of samples. The power of the study is expressed as 1-β (β = probability of type II error), and in general, studies must have 80% power. The number of samples was determined as 135 in total, 45 people in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- It is a prospective intervention type three-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as web-based diabetic foot training, Group-2 (Experiment) was designed s face-to-face diabetic foot training, and Group-3 (Control) was designed as clinical routine training.
| Arm | Type | Receives |
|---|---|---|
| Group-1 (Web-based diabetic foot education applied group) | Experimental | Other: Web-based diabetic foot education based on health promotion model1. In the first interview, individuals in the web training group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, a username and password will be defined for individuals in the web training group so that they can log in to the diabetic foot web training page. 3. Patients will be trained on how to access the diabetic foot web training page, how to access information, and how to use videos. 4. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews. |
| Group-2 (Face to face diabetic foot education applied group) | Experimental | Other: Face to face diabetic foot education based on health promotion model1. In the first meeting for individuals in the face-to-face education group; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, face-to-face diabetic foot training will be given in accordance with the training booklet for approximately 45 minutes. 3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews. |
| Group-3 Clinical routine education applied group (control) | No intervention | –1. In the first interview, individuals in the control group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Foot Care Behavior Checklist, Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, individuals in the control group will receive routine training given by the training nurse on duty in the diabetes education unit. Education based on the health promotion model will not be implemented. 3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having been diagnosed with type 2 diabetes at least 6 months ago according to ADA criteria
- Being between the ages of 18 and 80
- Ability to read and write
- Not having received diabetic foot training before
- No existing foot ulcers
Key exclusion criteria (2 listed)
- Wants to leave the study
- Foot ulcer development in a diabetic individual during work
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 |
|---|---|---|
| Web-based diabetic foot education based on health promotion modelThe first group can access the training at any time and repeat the training thanks to web-based training. | Other | Group-1 (Web-based diabetic foot education applied group) |
| Face to face diabetic foot education based on health promotion modelIndividuals with Type 2 diabetes in the face-to-face training group will receive face-to-face diabetic foot training in line with the training booklet for approximately 45 minutes, one by one. | Other | Group-2 (Face to face diabetic foot education applied group) |
Primary outcome
Diabetes Foot Knowledge Level
Time frame: The knowledge level of the patients is measured with the 5-item "Diabetes Foot Knowledge Qustionnare" ; It will be evaluated before the training, in the first month and in the third month after the training.
The scale consists of 5 items and has no subdimensions. In the evaluation of the scale, the total score of the correct questions from the answers given as 'yes' or 'no' to the knowledge question constitutes the scale score. The scoring changez as 1 or 0. An increase in the scale score indicates an increase in the level of knowledge of diabetic feet.
Foot Care Behavior
Time frame: Patients' foot care behaviors will be questioned with the "Foot Self Care Observation Guide" consisting of 15 items; It will be evaluated before the training, in the first month and in the third month after the training.
The scale consists of 15 items and has no sub-dimensions. These items are evaluated as '1=Never', '2=Occasionally', '3=Sometimes', '4=Often', '5=Always'. The lowest score on the scale is 15 and the highest score is 75. An increase in the scale score indicates that the individual's self-care behaviors are better.
Foot Care Self-Efficacy
Time frame: Patients' foot care self-efficacy is evaluated with the "Diabetic Foot Care Self Efficacy" consisting of 9 items; It will be evaluated before the training, in the first month and in the third month after the training.
The scale consists of nine items. These nine statements are evaluated on an 11-number visual scale such as 'I don't see it at all adequate = 0' and 'I consider it very adequate = 10'. The lowest score from the scale is 0 and the highest score is 90. An increase in the scale score indicates that the individual's self-efficacy is high.
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 17 Jan 2025.
- Results publication: PubMed 32115378Sahin S, Cingil D. Evaluation of the relationship among foot wound risk, foot self-care behaviors, and illness acceptance in patients with type 2 diabetes mellitus. Prim Care Diabetes. 2020 Oct;14(5):469-475. doi: 10.1016/j.pcd.2020.02.005. Epub 2020 Feb 27.
- Results publication: PubMed 32192488Pourkazemi A, Ghanbari A, Khojamli M, Balo H, Hemmati H, Jafaryparvar Z, Motamed B. Diabetic foot care: knowledge and practice. BMC Endocr Disord. 2020 Mar 20;20(1):40. doi: 10.1186/s12902-020-0512-y.
- Results publication: PubMed 33048829Kilic M, Karadag A. Developing and Evaluating a Mobile Foot Care Application for Persons With Diabetes Mellitus: A Randomized Pilot Study. Wound Manag Prev. 2020 Oct;66(10):29-40.
- Results publication: PubMed 22872044Chau JP, Chung LC, Wong RY, Loo KM, Lo SH, So TT, Lau MS, Yeung TH, Leung BS, Tong ML, Li CY, Kwok WW, Thompson DR, Lee DT. An evaluation of a web-based diabetes education program designed to enhance self-management among patients living with diabetes. Comput Inform Nurs. 2012 Dec;30(12):672-9. doi: 10.1097/NXN.0b013e318261f1d2.
- Results publication: PubMed 31311727Abrar EA, Yusuf S, Sjattar EL, Rachmawaty R. Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Prim Care Diabetes. 2020 Apr;14(2):104-110. doi: 10.1016/j.pcd.2019.06.005. Epub 2019 Jul 13.
- Diabetes Foot Knowledge QustionnareLink provided by the sponsor.
- Foot Self Care Observation GuideLink provided by the sponsor.
- Diabetic Foot Care Self Efficacy ScaleLink provided by the sponsor.
- 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.
Aysun Kürkçü principal investigator
Kartal Dr.Lütfi Kırdar City Hospital İstanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based diabetic foot education based on health promotion model and Face to face diabetic foot education based on health promotion model in people with Diabetic Foot and Diabetes Mellitus Type 2, run by Marmara 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 9 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: under way, not looking for participants, as of the sponsor's last update on 17 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?
Diabetes Foot Knowledge Level (time frame: The knowledge level of the patients is measured with the 5-item "Diabetes Foot Knowledge Qustionnare" ; It will be evaluated before the training, in the first month and in the third month after the training.). 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?
On the ClinicalTrials.gov record for NCT06780631, which also lists 5 linked publications.
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 17 Jan 2025.