Diabetic FootNCT06358846
Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan.
A study testing Self-care behavior to promote foot care through educational guidance among individual with diabetes in people with Diabetic Foot and Educational Intervention, run by SINA Health Education and Welfare Trust at 1 site in Pakistan.
Trial summary
There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Educational Intervention, Foot Care
- What is being tested?
- Self-care behavior to promote foot care through educational guidance among individual with diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to 31 Aug 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients aged 18 years or older.
- Patients who are registered at designated SINA clinic and clinical and biochemical diagnosis of DM for at least six months
- Patients who are able to understand Urdu language will be included in the study
- Patients who are voluntarily participated the study will be included.
Who cannot join
- Patients come with recurrent foot ulcers or gangrene.
- History of amputation
- Patient live in other than designated slums location.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan. A Randomize Control Trial.
There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial.
- Being tested
- Self-care behavior to promote foot care through educational guidance among individual with diabetes
- Keywords
- Type 2 Diabetes, slums population, vulnerable population, low-socioeconomic status, Diabetes foot care, Knowledge on foot care
- 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.
Self-care behavior to promote foot care through educational guidance among individual with diabetesBehavioural
Apart from physician consultation, individuals will received structured training of how to care their foot to avoid ulcer and inflammation.
| Study group | Role | What they receive |
|---|---|---|
| standard care advice | No intervention | The control group will simply get standard advice from clinicians at the clinic during consultations. |
| standard care advice+ structured training through pictures containing learning pamphlet | Experimental | Interventional group will receive standard advice from clinician along with the structured training from qualified diabetes' educator through pictures containing learning pamphlet Receives: Behavioral: Self-care behavior to promote foot care through educational guidance among individual with diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Foot Care Knowledge
One potential outcome will be an increase in knowledge among participants regarding foot care practices specific to managing diabetes. This will include understanding the importance of proper footwear, regular foot inspections, and hygiene practices.
Measured: Time Frame: Three months after patient counselling towards foot care
Behavior Change
The educational intervention will lead to positive changes in behavior related to foot care. Participants will be more likely to engage in recommended foot care practices such as daily foot inspections, avoiding walking barefoot, and seeking prompt medical attention for any foot-related issues.
Measured: Time Frame: Three months after patient counselling towards foot care
Secondary outcomes (2)
Reduction in Foot Complications
A successful educational intervention will potentially lead to a decrease in foot complications among individuals with Type 2 Diabetes. This will include a reduction in foot ulcers, infections, and amputations, ultimately improving participants' overall quality of life.
Measured: 3 months
Empowerment and Self-efficacy
Participation in the educational intervention will empower individuals to take greater control of their diabetes management, leading to increased self-efficacy in managing their condition. This will result in improved confidence in their ability to prevent and manage foot complications.
Measured: Three months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 May 2024
- Primary completion15 Aug 2024
- Study completion31 Aug 2024
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 Diabetic FootStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control arm =75 Interventional arm = 75
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- SINA Health Education and Welfare Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Principal investigator, Hina Sharif, SINA Health Education and Welfare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358846
- Sponsor's protocol ID
- 00004
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sharif H, Kadir M, Hashmi M, Naz S, Azam I, Imam A, Masood MQ. Effectiveness of pictorial educational intervention on foot care among individuals having type 2 diabetes at slums of Karachi, Pakistan: asingle blinded randomized control trial. BMC Public Health. 2025 Sep 30;25(1):3214. doi: 10.1186/s12889-025-23969-6.
PubMed 41029643
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan. A Randomize Control Trial.
- ClinicalTrials.gov ID
- NCT06358846
- Acronym / sponsor ID
- 00004
- Keywords
- Type 2 Diabetes, slums population, vulnerable population, low-socioeconomic status, Diabetes foot care, Knowledge on foot care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- SINA Health Education and Welfare TrustUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 11 Apr 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.
There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control arm =75 Interventional arm = 75
| Arm | Type | Receives |
|---|---|---|
| standard care advice | No intervention | –The control group will simply get standard advice from clinicians at the clinic during consultations. |
| standard care advice+ structured training through pictures containing learning pamphlet | Experimental | Behavioral: Self-care behavior to promote foot care through educational guidance among individual with diabetesInterventional group will receive standard advice from clinician along with the structured training from qualified diabetes' educator through pictures containing learning pamphlet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients aged 18 years or older.
- Patients who are registered at designated SINA clinic and clinical and biochemical diagnosis of DM for at least six months
- Patients who are able to understand Urdu language will be included in the study
- Patients who are voluntarily participated the study will be included.
Key exclusion criteria (3 listed)
- Patients come with recurrent foot ulcers or gangrene.
- History of amputation
- Patient live in other than designated slums location.
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 behavior to promote foot care through educational guidance among individual with diabetesApart from physician consultation, individuals will received structured training of how to care their foot to avoid ulcer and inflammation. | Behavioural | standard care advice+ structured training through pictures containing learning pamphlet |
Primary outcome
Improved Foot Care Knowledge
Time frame: Time Frame: Three months after patient counselling towards foot care
One potential outcome will be an increase in knowledge among participants regarding foot care practices specific to managing diabetes. This will include understanding the importance of proper footwear, regular foot inspections, and hygiene practices.
Behavior Change
Time frame: Time Frame: Three months after patient counselling towards foot care
The educational intervention will lead to positive changes in behavior related to foot care. Participants will be more likely to engage in recommended foot care practices such as daily foot inspections, avoiding walking barefoot, and seeking prompt medical attention for any foot-related issues.
2 secondary outcomes
Reduction in Foot Complications
Time frame: 3 months
Empowerment and Self-efficacy
Time frame: Three months treatment
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 2024.
- Derived from this study: PubMed 41029643Sharif H, Kadir M, Hashmi M, Naz S, Azam I, Imam A, Masood MQ. Effectiveness of pictorial educational intervention on foot care among individuals having type 2 diabetes at slums of Karachi, Pakistan: asingle blinded randomized control trial. BMC Public Health. 2025 Sep 30;25(1):3214. doi: 10.1186/s12889-025-23969-6.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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?
A study testing Self-care behavior to promote foot care through educational guidance among individual with diabetes in people with Diabetic Foot and Educational Intervention, run by SINA Health Education and Welfare Trust at 1 site in Pakistan.
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 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 1 Oct 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 Pakistan. 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?
Improved Foot Care Knowledge (time frame: Time Frame: Three months after patient counselling towards foot care). 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 NCT06358846, 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 2024.