Diabetes MellitusDMumecPRONCT05061602
Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Tülay Çevik Saldıran at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Evaluation of biomechanics and viscoelastic properties of plantar fascia
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2021to 10 Jul 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Evaluation of biomechanics and viscoelastic properties of plantar fascia
- Keywords
- Plantar Fascia, Stiffness, Diabetes mellitus, Fear
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of biomechanics and viscoelastic properties of plantar fasciaDiagnostic test
Also called Falls Efficacy Scale
The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fascia | |
| NonDiabetic Group | The healthy age-matched control group was included. Receives: Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical and Viscoelastic Properties
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.
Measured: Day 1.
Secondary outcomes (2)
Fear of Falling
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.
Measured: Day 1.
Lower Limb Function
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.
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start20 Sep 2021
- Primary completion30 May 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tülay Çevik Saldıran
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Sponsor-investigator, Tülay Çevik Saldıran, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061602
- Sponsor's protocol ID
- BitlisErenUn
- Acronym
- DMumecPRO
- Status last verified
- Jul 2023
- First submitted
- 20 Sep 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05061602
- Acronym / sponsor ID
- DMumecPRO / BitlisErenUn
- Conditions
- Diabetes Mellitus
- Keywords
- Plantar Fascia, Stiffness, Diabetes mellitus, Fear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tülay Çevik SaldıranUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Group | – | Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fasciaThe patients were included if they were of 18 years or older, with a diagnosis of diabetes mellitus for more than three years. |
| NonDiabetic Group | – | Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fasciaThe healthy age-matched control group was included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of biomechanics and viscoelastic properties of plantar fasciaAlso: Falls Efficacy ScaleThe biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device. | Diagnostic test | Diabetic Group, NonDiabetic Group |
Primary outcome
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.
2 secondary outcomes
Fear of Falling
Time frame: Day 1.
Lower Limb Function
Time frame: Day 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Tülay Çevik Saldıran at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomechanical and Viscoelastic Properties (time frame: Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.