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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

Tracking Information
First Submitted Date May 29, 2020
First Posted Date June 23, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date December 1, 2017
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2020)
  • the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550) [ Time Frame: 6 months ]
    balance
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: June 20, 2020)
  • the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550) [ Time Frame: 6 months ]
    balance
  • Foot Function Index [ Time Frame: 6 months ]
    foot function
  • Manchester Foot Pain and Disability Index [ Time Frame: 6 months ]
    foot pain and disability
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus
Official Title Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Diabetes Mellitus
Condition Diabetes Mellitus
Intervention Diagnostic Test: balance test
balance test
Study Groups/Cohorts obese, non-obese
obese and non-obese diabetic patients
Intervention: Diagnostic Test: balance test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2020)
54
Original Actual Enrollment Same as current
Actual Study Completion Date May 30, 2018
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04444375
Other Study ID Numbers 60116787-020/71494
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mehmet Duray, Suleyman Demirel University
Study Sponsor Suleyman Demirel University
Collaborators Not Provided
Investigators
Principal Investigator: Mehmet Duray Suleyman Demirel University
PRS Account Suleyman Demirel University
Verification Date June 2020