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CompletedNCT04444375Updated Jun 30, 2020

Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus

An observational study in Diabetes Mellitus, sponsored by Suleyman Demirel University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 35 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by Suleyman Demirel University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
54
Ages
35 Years to 64 Years
Sex
All
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Study summary

Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common risk factors for plantar pain and related disability. The aim of our study was to evaluate the relationship between plantar pain, balance and foot function in diabetic DM patients has with different BMI.

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Conditions studied

  • Diabetes Mellitus

Keywords

  • Diabetes Mellitus
  • plantar pain
  • body mass index
  • obesity
  • balance
  • foot pain
  • disability
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In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 54 is below the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Suleyman Demirel University is the lead sponsor of 127 studies on the registry; 36 are open to participants now.

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

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Who can participate

Ages eligible
35 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Diabetes Mellitus

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

  • having plantar pain
  • and no change in BMI by more than 10% for at least 3 months
  • being volunteer to participate to the study

Exclusion criteria

Exclusion Criteria:

  • having musculoskeletal surgery for foot
  • having neurological, orthopedic, and cardiovascular diseases
  • vision and hearing problems that may cause balance disorder
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No

Groups and cohorts

  • obese, non-obese

    obese and non-obese diabetic patients

    Diagnostic Test: balance test

Interventions

  • Diagnostic testbalance test

    balance test

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What researchers measure

Primary outcomes

  1. the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)

    balance

    Time frame: 6 months

  2. Foot Function Index

    Foot Function Index of 23 items, and evaluates the pain, disability and activity limitation. The each of the pain and insufficiency subscales consist of 9 items and the activity limitation subscale includes 5 items. Patients score their foot pain level with Visual Analogue Scale (VAS) in various situations during the last 1 week. To calculate the scores of the index, the score of each item are summed, then divided by possible the maximum score can be obtained from the FFI. Higher scores indicate greater pain, disability and activity limitation level.

    Time frame: 6 months

  3. Manchester Foot Pain and Disability Index

    Manchester Foot Pain and Disability Index consists of 4 subsections including 9 questions for inadequacy, 5 questions for pain, 3 questions for concern and 2 questions for difficulty. Each item is scored between 0-2. The total score is calculated by summing the scores from all items. Higher scores indicate worse health situation.

    Time frame: 6 months

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Study locations

1 site
  • Mehmet Duray
    Isparta, 32200, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04444375
Responsible party
Mehmet Duray (Principal Investigator, Suleyman Demirel University) — Principal investigator
First posted
Jun 23, 2020
Start date
Dec 1, 2017
Primary completion
May 30, 2018
Completion
May 30, 2018
Last update
Jun 30, 2020

Study contacts

Mehmet Duray
principal investigator · Suleyman Demirel University

Oversight

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 Jun 2020. You cannot join it, but the record below documents what was studied.

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