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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04444375

Enrollment

Registered

2020-06-23

Start date

2017-12-01

Completion date

2018-05-30

Last updated

2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, plantar pain, body mass index, obesity, balance, foot pain, disability

Brief 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.

Interventions

DIAGNOSTIC_TESTbalance test

balance test

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 64 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)	6 months	balance
Foot Function Index	6 months	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.
Manchester Foot Pain and Disability Index	6 months	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026