Diabetes MellitusNCT06813794
The Effect of Message Framing in Diabetic Foot Self-Management
A study testing Gain- Framed Messages and Lost Framed Messages in people with Diabetes Mellitus, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to assess how effective gain- and loss-framed messages are in improving diabetic foot care behaviors and increasing self-efficacy levels compared to routine foot care messages. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Gain- Framed Messages and Lost Framed Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 28 May 2026
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged between 18 and 55 years.
- Individuals diagnosed with diabetes for at least six months.
- Individuals without diabetic foot ulcers or amputations.
- Individuals without any communication disorders or psychiatric illnesses.
- Individuals who are members of a social media platform.
- Individuals who can use a smartphone and have internet access.
- Individuals willing to participate in the study.
- Individuals with at least a primary school education.
Who cannot join
- Individuals diagnosed with diabetes (This criterion seems unclear; please clarify if it should refer to a specific diabetes-related condition).
- Individuals with diabetic foot ulcers or amputations.
- Individuals with any communication disorders or psychiatric illnesses.
- Individuals without access to a smartphone or the internet.
- Individuals with malingering disorders.
- Individuals who are illiterate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Message Framing in Diabetic Foot Self-Management on Diabetic Foot Care Behaviors and Self-Efficacy: A Randomized Controlled Trial
This study aims to assess how effective gain- and loss-framed messages are in improving diabetic foot care behaviors and increasing self-efficacy levels compared to routine foot care messages.
Study Design:
Read more
A randomized controlled trial with three groups:
Experimental Group 1 (Gain-Framed): Participants receive gain-framed messages emphasizing the benefits of proper foot care.
Experimental Group 2 (Loss-Framed): Participants receive loss-framed messages highlighting the risks of inadequate foot care.
Control Group (Routine Messaging): Participants receive standard foot care messages without specific framing.
Participants:
Diabetic patients recruited from Experimental Group 1, Experimental Group, and Control Group 3. Inclusion criteria include adults diagnosed with diabetes who are at risk for diabetic foot complications.
Intervention:
Over a period of three months, participants will receive WhatsApp messages three times a week.
Gain-Framed Messages: Emphasize positive outcomes, such as preventing foot ulcers by wearing appropriate footwear.
Loss-Framed Messages: Highlight negative consequences, such as the increased risk of foot infections from improper foot care.
Messages will include supportive images and videos to enhance engagement and understanding.
Outcome Measures:
Primary Outcomes:
Foot Care Behavior: Assessed using The Foot Care Behavior Scale. Self-Efficacy: Measured by the Diabetic Foot Care Self-Efficacy Scale Secondary Outcomes: Comparative effectiveness between gain-framed and loss-framed messages.Long-term behavioral changes post-intervention.
Significance:
This study seeks to determine the most effective messaging strategy to promote diabetic foot care, potentially informing future interventions to reduce the incidence of diabetic foot complications.
Read the detailed description
Title: The Effect of Message Framing on Self-Efficacy and Foot Care Behaviors in Diabetic Foot Care: A Randomized Controlled Study
Abstract:
This study aims to examine the effect of message framing on self-efficacy and foot care behaviors in diabetic foot care. Evaluating the impact of message framing on self-efficacy and foot care behaviors is crucial in reducing the economic burden of diabetic foot on healthcare services while simultaneously improving patients' quality of life and daily functionality. The results of this study are expected to contribute to interventions aimed at enhancing self-efficacy in diabetic foot care and preventing diabetic foot complications.
Study Setting and Population:
Patients will be recruited through diabetes-related social media groups. Eligible participants who agree to participate will be contacted via WhatsApp, where they will receive framed messages.
Study Design and Methodology:
This study is designed as a three-arm randomized controlled trial.
Population and Sample: The study population consists of patients following diabetes-related social media groups. The sample will include individuals meeting the inclusion criteria and consenting to participate between May 15, 2024, and May 15, 2025. Participants will be randomly assigned to one of three groups: Experimental Group 1, Experimental Group 2, and Control Group 3. A three-month intervention will be implemented.
Sample Size Calculation: The sample size was determined using the G*Power 3.1.9.6 program. A three-group, two-measurement (pretest, posttest) design was considered. Based on an effect size of 0.50, a significance level of α = 0.05, and a power of 1-β = 0.80, the required sample size for each group was calculated as 49. Considering possible data loss, the sample size was increased by 10%, resulting in 54 participants per group and a total of 162 participants.
Randomization: Simple random sampling (lottery method) will be used. The lottery draw will be conducted by an independent person with no contact with the participants.
Intervention Procedure:
Participants in all groups will receive an online questionnaire via Google Forms, including a Patient Information Form, the Diabetic Foot Self-Efficacy Scale, and the Foot Care Behavior Scale.
Experimental Group 1: Participants will receive gain-framed messages about diabetic foot care via a WhatsApp group. Three times a week for three months, they will be sent gain-framed messages and videos. For example, a message emphasizing proper footwear and socks will state: "Wearing appropriate shoes and socks that reduce foot friction helps prevent foot ulcers caused by vascular damage." Healthy foot images and videos will accompany the messages.
Experimental Group 2: Participants will receive loss-framed messages via WhatsApp. Three times a week for three months, they will receive loss-framed messages and videos. An example message will be: "Wearing inappropriate shoes and socks that increase foot friction may lead to poor foot care and a higher risk of foot ulcers." Images of infected feet and videos of patients receiving treatment for diabetic foot complications will be shared.
Control Group 3: Participants will receive neutral messages regarding foot care without specific message framing. For example, they will receive the message: "You should wear appropriate shoes and socks to prevent foot friction."
At the end of the intervention, the Diabetic Foot Self-Efficacy Scale and Foot Care Behavior Scale will be re-administered.
Data Collection Tools:
Patient Information Form: Collects demographic data (age, gender, education level, date of diabetes diagnosis, presence of foot complications).
Diabetic Foot Self-Efficacy Scale: Developed by Bonnie Elliott Quarles in 2005 to assess diabetic patients' perceived ability to perform foot care activities. The Turkish validity and reliability study was conducted by Biçer and Enç in 2011. The 9-item scale is scored on a visual scale from 0 (not confident) to 10 (very confident), with a total score range of 0-90. A higher score indicates higher self-efficacy (Cronbach's α = 0.86).
Foot Care Behavior Scale: Originally developed by Borges in 2007 as the Foot Care Observation Guide and later adapted by Biçer and Enç in 2011. This 15-item Likert-type scale measures foot care behaviors, ranging from 1 (never) to 5 (always). The total score ranges from 15 to 75, with higher scores indicating better foot care behaviors (Cronbach's α = 0.83).
Limitations:
The study is limited to information measured by the surveys and to patients with internet access who voluntarily participate.
Ethical Considerations:
Ethical approval will be obtained from the Ethics Committee of Atatürk University Faculty of Medicine. Institutional permissions will be sought from relevant hospitals. Written informed consent will be obtained from participants.
Data Collection and Storage:
Data will be collected through Google Forms via WhatsApp after obtaining informed consent from voluntary participants.
Data Analysis:
Survey responses will be analyzed using SPSS software. Statistical analyses will include comparisons of pretest and posttest scores across groups using appropriate statistical methods.
Conclusion:
This study aims to evaluate the effectiveness of message framing on diabetic foot care self-efficacy and behaviors. Findings are expected to contribute to the development of targeted interventions that enhance diabetic foot care practices, reduce healthcare costs, and improve patients' quality of life.
- Conditions
- Diabetes Mellitus
- Being tested
- Gain- Framed Messages, Lost Framed Messages
- Keywords
- message framing, Diabetic foot care, Self-efficacy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gain- Framed MessagesBehavioural
Patients will be recruited to whatsapp group based on gain framing about diabetic foot care skills. Gain framing messages and videos will be delivered to patients via whatsapp 3 times a week for 3 months.
Lost Framed MessagesBehavioural
Patients will be included in whatsapp group based on Lost framing about diabetic foot care skills. Patients will receive loss framing messages and videos 3 times a week for 3 months via whatsapp.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Gain-Framed) | Experimental | Participants receive gain-framed messages emphasizing the benefits of proper foot care. Receives: Behavioral: Gain- Framed Messages |
| Control Group | No intervention | Participants will receive neutral messages about diabetic foot care. |
| Group 2 (Loss-Framed) | Experimental | Participants receive loss-framed messages highlighting the risks of inadequate foot care. Receives: Behavioral: Lost Framed Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic Foot Care Self-Sufficiency Level
Diabetic Foot Care Self-Efficacy Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3.
Primary Outcome: Change in Diabetic Foot Care Self-Efficacy Score from baseline to 3 months.
Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score that can be obtained from the Diabetic Foot Care Self-Efficacy Scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.
Measured: 3 months
Assessment of Foot Care Behavior
Foot Care Behavior Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Foot Care Behavior Scale from baseline to 3 months.
Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score of the Foot Care Behavior scale is 15 and the highest score is 75. The increase in the scale score indicates that the individual's self-care behaviors are better
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 May 2025
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap KAVURMACI, Ataturk University
- Investigators
- Mehtap Kavurmacı, Prof, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813794
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/327
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao R, Guo H, Liu Y, Pang Y, Zhang X, Lian X, Yu T, Zhu L, Li F. The effects of message framing on self-management behavior among people with type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2023 Jun;142:104491. doi: 10.1016/j.ijnurstu.2023.104491. Epub 2023 Mar 17.
PubMed 37059032
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Message Framing in Diabetic Foot Self-Management on Diabetic Foot Care Behaviors and Self-Efficacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06813794
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/327
- Conditions
- Diabetes Mellitus
- Keywords
- message framing, Diabetic foot care, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 7 Feb 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.
This study aims to assess how effective gain- and loss-framed messages are in improving diabetic foot care behaviors and increasing self-efficacy levels compared to routine foot care messages.
Study Design:
A randomized controlled trial with three groups:
Experimental Group 1 (Gain-Framed): Participants receive gain-framed messages emphasizing the benefits of proper foot care.
Experimental Group 2 (Loss-Framed): Participants receive loss-framed messages highlighting the risks of inadequate foot care.
Control Group (Routine Messaging): Participants receive standard foot care messages without specific framing.
Participants:
Diabetic patients recruited from Experimental Group 1, Experimental Group, and Control Group 3. Inclusion criteria include adults diagnosed with diabetes who are at risk for diabetic foot complications.
Intervention:
Over a period of three months, participants will receive WhatsApp messages three times a week.
Gain-Framed Messages: Emphasize positive outcomes, such as preventing foot ulcers by wearing appropriate footwear.
Loss-Framed Messages: Highlight negative consequences, such as the increased risk of foot infections from improper foot care.
Messages will include supportive images and videos to enhance engagement and understanding.
Outcome Measures:
Primary Outcomes:
Foot Care Behavior: Assessed using The Foot Care Behavior Scale. Self-Efficacy: Measured by the Diabetic Foot Care Self-Efficacy Scale Secondary Outcomes: Comparative effectiveness between gain-framed and loss-framed messages.Long-term behavioral changes post-intervention.
Significance:
This study seeks to determine the most effective messaging strategy to promote diabetic foot care, potentially informing future interventions to reduce the incidence of diabetic foot complications.
Detailed description
Title: The Effect of Message Framing on Self-Efficacy and Foot Care Behaviors in Diabetic Foot Care: A Randomized Controlled Study
Abstract:
This study aims to examine the effect of message framing on self-efficacy and foot care behaviors in diabetic foot care. Evaluating the impact of message framing on self-efficacy and foot care behaviors is crucial in reducing the economic burden of diabetic foot on healthcare services while simultaneously improving patients' quality of life and daily functionality. The results of this study are expected to contribute to interventions aimed at enhancing self-efficacy in diabetic foot care and preventing diabetic foot complications.
Study Setting and Population:
Patients will be recruited through diabetes-related social media groups. Eligible participants who agree to participate will be contacted via WhatsApp, where they will receive framed messages.
Study Design and Methodology:
This study is designed as a three-arm randomized controlled trial.
Population and Sample: The study population consists of patients following diabetes-related social media groups. The sample will include individuals meeting the inclusion criteria and consenting to participate between May 15, 2024, and May 15, 2025. Participants will be randomly assigned to one of three groups: Experimental Group 1, Experimental Group 2, and Control Group 3. A three-month intervention will be implemented.
Sample Size Calculation: The sample size was determined using the G*Power 3.1.9.6 program. A three-group, two-measurement (pretest, posttest) design was considered. Based on an effect size of 0.50, a significance level of α = 0.05, and a power of 1-β = 0.80, the required sample size for each group was calculated as 49. Considering possible data loss, the sample size was increased by 10%, resulting in 54 participants per group and a total of 162 participants.
Randomization: Simple random sampling (lottery method) will be used. The lottery draw will be conducted by an independent person with no contact with the participants.
Intervention Procedure:
Participants in all groups will receive an online questionnaire via Google Forms, including a Patient Information Form, the Diabetic Foot Self-Efficacy Scale, and the Foot Care Behavior Scale.
Experimental Group 1: Participants will receive gain-framed messages about diabetic foot care via a WhatsApp group. Three times a week for three months, they will be sent gain-framed messages and videos. For example, a message emphasizing proper footwear and socks will state: "Wearing appropriate shoes and socks that reduce foot friction helps prevent foot ulcers caused by vascular damage." Healthy foot images and videos will accompany the messages.
Experimental Group 2: Participants will receive loss-framed messages via WhatsApp. Three times a week for three months, they will receive loss-framed messages and videos. An example message will be: "Wearing inappropriate shoes and socks that increase foot friction may lead to poor foot care and a higher risk of foot ulcers." Images of infected feet and videos of patients receiving treatment for diabetic foot complications will be shared.
Control Group 3: Participants will receive neutral messages regarding foot care without specific message framing. For example, they will receive the message: "You should wear appropriate shoes and socks to prevent foot friction."
At the end of the intervention, the Diabetic Foot Self-Efficacy Scale and Foot Care Behavior Scale will be re-administered.
Data Collection Tools:
Patient Information Form: Collects demographic data (age, gender, education level, date of diabetes diagnosis, presence of foot complications).
Diabetic Foot Self-Efficacy Scale: Developed by Bonnie Elliott Quarles in 2005 to assess diabetic patients' perceived ability to perform foot care activities. The Turkish validity and reliability study was conducted by Biçer and Enç in 2011. The 9-item scale is scored on a visual scale from 0 (not confident) to 10 (very confident), with a total score range of 0-90. A higher score indicates higher self-efficacy (Cronbach's α = 0.86).
Foot Care Behavior Scale: Originally developed by Borges in 2007 as the Foot Care Observation Guide and later adapted by Biçer and Enç in 2011. This 15-item Likert-type scale measures foot care behaviors, ranging from 1 (never) to 5 (always). The total score ranges from 15 to 75, with higher scores indicating better foot care behaviors (Cronbach's α = 0.83).
Limitations:
The study is limited to information measured by the surveys and to patients with internet access who voluntarily participate.
Ethical Considerations:
Ethical approval will be obtained from the Ethics Committee of Atatürk University Faculty of Medicine. Institutional permissions will be sought from relevant hospitals. Written informed consent will be obtained from participants.
Data Collection and Storage:
Data will be collected through Google Forms via WhatsApp after obtaining informed consent from voluntary participants.
Data Analysis:
Survey responses will be analyzed using SPSS software. Statistical analyses will include comparisons of pretest and posttest scores across groups using appropriate statistical methods.
Conclusion:
This study aims to evaluate the effectiveness of message framing on diabetic foot care self-efficacy and behaviors. Findings are expected to contribute to the development of targeted interventions that enhance diabetic foot care practices, reduce healthcare costs, and improve patients' quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Gain-Framed) | Experimental | Behavioral: Gain- Framed MessagesParticipants receive gain-framed messages emphasizing the benefits of proper foot care. |
| Control Group | No intervention | –Participants will receive neutral messages about diabetic foot care. |
| Group 2 (Loss-Framed) | Experimental | Behavioral: Lost Framed MessagesParticipants receive loss-framed messages highlighting the risks of inadequate foot care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Individuals aged between 18 and 55 years.
- Individuals diagnosed with diabetes for at least six months.
- Individuals without diabetic foot ulcers or amputations.
- Individuals without any communication disorders or psychiatric illnesses.
- Individuals who are members of a social media platform.
Key exclusion criteria (6 listed)
- Individuals diagnosed with diabetes (This criterion seems unclear; please clarify if it should refer to a specific diabetes-related condition).
- Individuals with diabetic foot ulcers or amputations.
- Individuals with any communication disorders or psychiatric illnesses.
- Individuals without access to a smartphone or the internet.
- Individuals with malingering disorders.
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 |
|---|---|---|
| Gain- Framed MessagesPatients will be recruited to whatsapp group based on gain framing about diabetic foot care skills. Gain framing messages and videos will be delivered to patients via whatsapp 3 times a week for 3 months. | Behavioural | Group 1 (Gain-Framed) |
| Lost Framed MessagesPatients will be included in whatsapp group based on Lost framing about diabetic foot care skills. Patients will receive loss framing messages and videos 3 times a week for 3 months via whatsapp. | Behavioural | Group 2 (Loss-Framed) |
Primary outcome
Diabetic Foot Care Self-Sufficiency Level
Time frame: 3 months
Diabetic Foot Care Self-Efficacy Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Diabetic Foot Care Self-Efficacy Score from baseline to 3 months. Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score that can be obtained from the Diabetic Foot Care Self-Efficacy Scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.
Assessment of Foot Care Behavior
Time frame: 3 month
Foot Care Behavior Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Foot Care Behavior Scale from baseline to 3 months. Measurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score of the Foot Care Behavior scale is 15 and the highest score is 75. The increase in the scale score indicates that the individual's self-care behaviors are better
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 1 Oct 2026.
- Background: PubMed 37059032Gao R, Guo H, Liu Y, Pang Y, Zhang X, Lian X, Yu T, Zhu L, Li F. The effects of message framing on self-management behavior among people with type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2023 Jun;142:104491. doi: 10.1016/j.ijnurstu.2023.104491. Epub 2023 Mar 17.
- The International Working Group on the Diabetic Foot: Stories and Numbers Behind Three Decades of Evidence-Based Guidelines for the Management of Diabetes-Related Foot DiseaseLink 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.
Mehtap Kavurmacı, Prof study director
Ataturk 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 Gain- Framed Messages and Lost Framed Messages in people with Diabetes Mellitus, run by Ataturk 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 8 inclusion and 6 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 1 Oct 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?
Diabetic Foot Care Self-Sufficiency Level (time frame: 3 months). The study lists 2 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 NCT06813794, which also lists 1 linked publication.
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 1 Oct 2026.