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Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus (DMumecPRO)

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ClinicalTrials.gov Identifier: NCT05061602
Recruitment Status : Recruiting
First Posted : September 29, 2021
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Tülay Çevik Saldıran, Bitlis Eren University

Brief Summary:
In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.

Condition or disease Intervention/treatment
Diabetes Mellitus Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fascia

Detailed Description:
Chronic diabetes can lead to ulceration in the plantar region and may result in amputation. Diabetes-related foot ulcerations are one of the most challenging complications of diabetes mellitus. Myotonometry, a technique to measure dynamic stiffness is preferred due to its noninvasiveness, easy employability, and rapid investigation. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. Increased plantar tissue stiffness is thought to alter the distribution of tensile stresses in the plantar soft tissues during gait. Combined with a reduction in plantar tissue thickness, these changes could collectively decrease the mechanical loads required to initiate soft tissue breakdown and thus lead to foot ulceration formation. Diabetes mellitus is a significant risk factor for falls in adults and is associated with an increase in fear of falling. Microvascular complications associated with DM result in multiple impairments including sensory deficits and muscle weakness due to peripheral neuropathy, loss of visual acuity due to retinopathy, and impaired postural control and falls due to vestibulopathy. The prevalence of falls and fear of falling are significantly higher in adults with diabetes mellitus. Assessment of mechanical properties of plantar tissues can aid in the early diagnosis of ulceration. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : February 20, 2022
Estimated Study Completion Date : March 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Group/Cohort Intervention/treatment
Diabetic Group
The patients were included if they were of 18 years or older, with a diagnosis of diabetes mellitus for more than three years.
Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fascia
The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.
Other Name: Falls Efficacy Scale

NonDiabetic Group
The healthy age-matched control group was included.
Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fascia
The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.
Other Name: Falls Efficacy Scale




Primary Outcome Measures :
  1. Biomechanical and Viscoelastic Properties [ Time Frame: Day 1. ]
    The biomechanical and viscoelastic properties of the plantar fascia will be measured with MyotonPRO device. The MyotonPRO (Tallin, Estonia) is a portable hand-held myotonometer. This device is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by different parameters such as tone, elasticity, and stiffness. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.


Secondary Outcome Measures :
  1. Fear of Falling [ Time Frame: Day 1. ]
    Fear of falling will be assessed using the Falls Efficacy Scale International questionnaire. In this scale, scores are treated as continuous variables ranging from 16 to 64, where 16 indicates no concern and 64 indicates severe concern about falling. Participants in this study were further classified as having had low concern (score of 16-19), moderate concern (score of 20-27), or high concern (score ≥28) about falling.

  2. Lower Limb Function [ Time Frame: Day 1. ]
    The Short Physical Performance Battery will be used for Lower limb function assessment. It is an objective measure of lower-extremity function that includes 4-meter gait speed at usual pace, three standing balance tests, and time to complete five chair rises Composite scores range from 0 to 12 with higher scores reflecting better performance.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of diabetes mellitus for more than three years or individuals without a history of diabetes mellitus affirmed by a normal range of fasting blood sugar and hemoglobin A1C levels.
Criteria

Inclusion Criteria:

  • Diagnosed with diabetes mellitus for more than three years
  • Individuals without a history of diabetes mellitus affirmed by a normal range of fasting blood sugar and hemoglobin A1C levels.
  • Age≥18 years

Exclusion Criteria:

  • History of central nervous system conditions
  • No visual and vestibular impairments
  • Amputation of the lower limb
  • History of fracture
  • Surgery of lumbar and lower limb
  • Having pain resulting in movement difficulty

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): NCT05061602


Locations
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Turkey
Bitlis State Hospital Recruiting
Bitlis, Turkey, 13000
Contact: Tülay Saldıran    4342220000    tlyfztcvk@gmail.com   
Principal Investigator: Tülay Saldıran, Ph.D.         
Sponsors and Collaborators
Bitlis Eren University
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Responsible Party: Tülay Çevik Saldıran, Principal Investigator, Bitlis Eren University
ClinicalTrials.gov Identifier: NCT05061602    
Other Study ID Numbers: BitlisErenUn
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021

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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 Tülay Çevik Saldıran, Bitlis Eren University:
Plantar Fascia
Stiffness
Diabetes mellitus
Fear
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases