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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04444375
Recruitment Status : Completed
First Posted : June 23, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mehmet Duray, Suleyman Demirel University

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Diagnostic Test: balance test

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Group/Cohort Intervention/treatment
obese, non-obese
obese and non-obese diabetic patients
Diagnostic Test: balance test
balance test




Primary Outcome Measures :
  1. the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550) [ Time Frame: 6 months ]
    balance

  2. Foot Function Index [ Time Frame: 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.

  3. Manchester Foot Pain and Disability Index [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetes Mellitus
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04444375


Locations
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Turkey
Mehmet Duray
Isparta, Turkey, 32200
Sponsors and Collaborators
Suleyman Demirel University
Investigators
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Principal Investigator: Mehmet Duray Suleyman Demirel University
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Responsible Party: Mehmet Duray, Principal Investigator, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT04444375    
Other Study ID Numbers: 60116787-020/71494
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Duray, Suleyman Demirel University:
Diabetes Mellitus
plantar pain
body mass index
obesity
balance
foot pain
disability
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases