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CompletedNCT06358846Updated Oct 1, 2024

Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan.

An interventional study of Self-care behavior to promote foot care through educational guidance among individual with diabetes in Diabetic Foot, Educational Intervention and Foot Care, sponsored by SINA Health Education and Welfare Trust. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by SINA Health Education and Welfare Trust · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetic Foot
  • Educational Intervention
  • Foot Care
  • Foot Ulcer, Diabetic
  • Foot Cellulitis

Keywords

  • Type 2 Diabetes
  • slums population
  • vulnerable population
  • low-socioeconomic status
  • Diabetes foot care
  • Knowledge on foot care
03

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 150 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

SINA Health Education and Welfare Trust is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    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.

Exclusion criteria

Exclusion Criteria:

  • Patients come with recurrent foot ulcers or gangrene.
  • History of amputation
  • Patient live in other than designated slums location.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • No intervention
    standard care advice

    The control group will simply get standard advice from clinicians at the clinic during consultations.

  • Experimental
    standard care advice+ structured training through pictures containing learning pamphlet

    Interventional group will receive standard advice from clinician along with the structured training from qualified diabetes' educator through pictures containing learning pamphlet

    Behavioral: Self-care behavior to promote foot care through educational guidance among individual with diabetes

Interventions

  • BehavioralSelf-care behavior to promote foot care through educational guidance among individual with diabetes

    Apart from physician consultation, individuals will received structured training of how to care their foot to avoid ulcer and inflammation.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Time Frame: Three months after patient counselling towards foot care

  2. 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.

    Time frame: Time Frame: Three months after patient counselling towards foot care

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: Three months treatment

07

Study locations

1 site
  • SINA Mewasha & North Clinic
    Karachi, Sindh 75850, Pakistan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Aug 2024, 3 months.

Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 3 months is below that.

Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2024
First posted
Apr 11, 2024
StartActual
May 15, 2024
Primary completionActual
Aug 15, 2024
CompletionActual
Aug 31, 2024
Last update
Oct 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06358846
Lead sponsor
SINA Health Education and Welfare Trust
Collaborators
Aga Khan University
Responsible party
Hina Sharif (Assistant Manager, SINA Health Education and Welfare Trust) — Principal investigator
First posted
Apr 11, 2024
Start date
May 15, 2024
Primary completion
Aug 15, 2024
Completion
Aug 31, 2024
Last update
Oct 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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