Clinical trial NCT05061602: Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
Official title: Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Plantar Fascia
Stiffness
Diabetes mellitus
Fear
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
Collaborators: name: Okan University
First posted: 2021-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Biomechanical and Viscoelastic Properties
timeFrame: Day 1.
Secondary outcomes:
measure: Fear of Falling
timeFrame: Day 1.
measure: Lower Limb Function
timeFrame: Day 1.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University Hospital
Study officials:
References: