Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-21 @ 2:13 AM
Study NCT ID:
NCT07164495
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Developing Peak Plantar Pressure During Walking in the Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plantar pressure', 'timeFrame': 'Day 1: a single time point', 'description': 'Pressure insole will be inserted into the standard shoes to record plantar pressure values during level walking'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Gait', 'Plantar Pressure'], 'conditions': ['Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the clinically convenient dynamic and static measurement parameters to identify related risk factors of developing high peak plantar pressure during walking in the type-2 diabetic patients, and then establish a predictive model to estimate the likelihood of excessive plantar pressure.\n\nThe main question it aims to answer is:\n\nWhich clinical measurements may be used as the predictors that increased peak plantar pressure in the type-2 diabetic patients? Participants taking the examinations will understand their own clinally meaningful measurements related to their plantar pressure during walking. Further thorough analysis will be employed to develop a predictive model, aiming to provide potential improvement strategies for preventing diabetic foot ulcers in the future.', 'detailedDescription': "Diabetes is one of the top three chronic diseases among the population, with type 2 diabetes accounting for 90% of all cases. Due to decreased insulin sensitivity, the body cannot effectively store glucose in muscle, fat, and liver cells, leading to elevated blood sugar levels. This condition often results in various comorbidities and complications, with diabetic peripheral neuropathy (DPN) being the most prominent. DPN symptoms include loss of sensation to pain, pressure, vibration, proprioception, and temperature changes, which can lead to foot ulcers and altered gait in patients. The primary risk factor for diabetic foot ulcers is excessive or concentrated plantar pressure. Currently, the main preventive measure for diabetic foot ulcers is the use of insoles or footwear to reduce foot pressure. However, the difficulty in obtaining plantar pressure monitoring equipment limits its widespread clinical use. In contrast, assessments of foot morphology and range of motion (ROM), as well as the application of new sensors for gait kinematic measurement, are relatively convenient for clinical use. Therefore, this study aims to establish the relationship between peak plantar pressure during walking in diabetic patients and clinically convenient dynamic and static measurement parameters, identify related risk factors, and develop a predictive model to estimate the likelihood of excessive plantar pressure.\n\nThe study plans to recruit 120 diabetic patients, using the NDS scale to measure participants' neuropathy disability levels, Von Frey monofilaments to assess plantar sensation, goniometers to record joint angles of the first metatarsophalangeal joint, ankle, and knee, graph paper to record foot shape, RehaGait(R) gait analysis system to record walking kinematics, and Noraxon(R) Ultium Insole to record plantar pressure values. Subsequently, correlation analysis will be used to identify the relationship between joint angles, foot shape, walking kinematics, and peak plantar pressure values, while chi-square tests will identify significant risk factors. Finally, multiple regression analysis will be employed to develop a predictive model, aiming to provide potential improvement strategies for preventing diabetic foot ulcers in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'those diagnosed with type 2 diabetes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with type 2 diabetes, at least for five years\n* aged older than 18 years\n* walk independently for at least 10 meter without any assistive device\n\nExclusion Criteria:\n\n* severe deformity in the foot or lower extremity\n* significant neuropathic or surgical diseases that affect normal walking function\n* cognitive dysfunction\n* active foot ulcer'}, 'identificationModule': {'nctId': 'NCT07164495', 'briefTitle': 'Risk Factors for Developing Peak Plantar Pressure During Walking in the Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Investigation of the Risk Factors and Establishing a Prediction Model for Developing Peak Foot Pressure During Walking in the Diabetic Patients', 'orgStudyIdInfo': {'id': 'CMUH113-REC1-169'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 2 diabetes', 'description': '1. Diagnosed with type 2 diabetes;\n2. Able to walk at least 10 meters independently without any assistive device;\n3. Age \\> 18 years.\n4. No acute foot ulcers, any lower limb deformity or surgery, neurological disease that may affect walking function.\n5. No Cognitive impairment and inability to follow instructions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '406040', 'city': 'Taichung', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsiu-Chen Lin', 'role': 'CONTACT', 'email': 'hclin@mail.cmu.edu.tw', 'phone': '0422053366'}], 'facility': 'China Medical University, Department of Physical Therapy', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Hsiu-Chen Lin, PhD', 'role': 'CONTACT', 'email': 'hclin@mail.cmu.edu.tw', 'phone': '+886422053366', 'phoneExt': '7303'}, {'name': 'Ming-Chen Hsieh, MD, PhD', 'role': 'CONTACT', 'phone': '+886-3-5580-558'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Medical University, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hsiu-Chen Lin', 'investigatorAffiliation': 'China Medical University, Taiwan'}}}}