- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05061602
Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus (DMumecPRO)
July 26, 2023 updated by: Tülay Çevik Saldıran
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34959
- Okan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.
Other Names:
|
NonDiabetic Group
The healthy age-matched control group was included.
|
The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1.
|
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.
|
Day 1.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2021
Primary Completion (Actual)
May 30, 2022
Study Completion (Actual)
July 10, 2022
Study Registration Dates
First Submitted
September 20, 2021
First Submitted That Met QC Criteria
September 20, 2021
First Posted (Actual)
September 29, 2021
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BitlisErenUn
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on Evaluation of biomechanics and viscoelastic properties of plantar fascia
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedPelvic Girdle Pain | Pregnant Woman | Biomechanical and Viscoelastic Properties of Plantar FasciaTurkey
-
Sultan Abdulhamid Han Training and Research Hospital...RecruitingPregnant WomenTurkey
-
Sultan Abdulhamid Han Training and Research Hospital...Not yet recruiting
-
Sultan Abdulhamid Han Training and Research Hospital...Not yet recruitingPregnant WomenTurkey
-
Sultan Abdulhamid Han Training and Research Hospital...Not yet recruitingPregnant Women | Pelvic Girdle PainTurkey
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
Simge DönmezCompletedInvestigation of the Effect of Foot Muscle Fatigue on the Foot Sole and Tendon Structural PropertiesHealthy ParticipantsTurkey
-
Sohag UniversityNot yet recruitingin Cases of Chronic Resistant Plantar FasciopathyEgypt
-
Sultan Qaboos UniversityRecruitingPlantar FascitisOman
-
University of FaisalabadCompletedPlantar FasciitisPakistan