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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: balance test

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey, 32200
    • Mehmet Duray

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Diabetes Mellitus

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obese, non-obese; obese and non-obese diabetic patients	Diagnostic test: balance test; balance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)	balance	6 months
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Suleyman Demirel University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: body mass index; Diabetes Mellitus; obesity; disability; balance; foot pain; plantar pain
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 60116787-020/71494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No