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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444375
• Other study ID #: 60116787-020/71494
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: June 2020
• Source: Suleyman Demirel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Diagnostic Test:
• balance test
balance test

Locations

Country	Name	City	State
Turkey	Mehmet Duray	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)	balance	6 months
Primary	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
Primary	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