Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus

NCT ID: NCT05061602

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Evaluation of biomechanics and viscoelastic properties of plantar fascia

Intervention Type DIAGNOSTIC_TEST

The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.

NonDiabetic Group

The healthy age-matched control group was included.

Evaluation of biomechanics and viscoelastic properties of plantar fascia

Intervention Type DIAGNOSTIC_TEST

The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Falls Efficacy Scale

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Okan University

OTHER

Sponsor Role collaborator

Tülay Çevik Saldıran

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tülay Çevik Saldıran

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Okan University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BitlisErenUn

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Insoles in Plantar Fasciitis
NCT06563492 NOT_YET_RECRUITING NA