Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05061602
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomechanical and Viscoelastic Properties', 'timeFrame': 'Day 1.', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Fear of Falling', 'timeFrame': 'Day 1.', 'description': '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.'}, {'measure': 'Lower Limb Function', 'timeFrame': 'Day 1.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plantar Fascia', 'Stiffness', 'Diabetes mellitus', 'Fear'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with diabetes mellitus for more than three years\n* Individuals without a history of diabetes mellitus affirmed by a normal range of fasting blood sugar and hemoglobin A1C levels.\n* Age≥18 years\n\nExclusion Criteria:\n\n* History of central nervous system conditions\n* No visual and vestibular impairments\n* Amputation of the lower limb\n* History of fracture\n* Surgery of lumbar and lower limb\n* Having pain resulting in movement difficulty'}, 'identificationModule': {'nctId': 'NCT05061602', 'acronym': 'DMumecPRO', 'briefTitle': 'Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Bitlis Eren University'}, 'officialTitle': 'Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'BitlisErenUn'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic Group', 'description': 'The patients were included if they were of 18 years or older, with a diagnosis of diabetes mellitus for more than three years.', 'interventionNames': ['Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fascia']}, {'label': 'NonDiabetic Group', 'description': 'The healthy age-matched control group was included.', 'interventionNames': ['Diagnostic Test: Evaluation of biomechanics and viscoelastic properties of plantar fascia']}], 'interventions': [{'name': 'Evaluation of biomechanics and viscoelastic properties of plantar fascia', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Falls Efficacy Scale'], 'description': 'The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.', 'armGroupLabels': ['Diabetic Group', 'NonDiabetic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34959', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Okan University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tülay Çevik Saldıran', 'class': 'OTHER'}, 'collaborators': [{'name': 'Okan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Tülay Çevik Saldıran', 'investigatorAffiliation': 'Bitlis Eren University'}}}}