Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT07022093
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Custom-Designed 3D-Printed and CAD-CAM Insoles on Individuals With Flexible Flatfoot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005413', 'term': 'Flatfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061826', 'term': 'Foot Orthoses'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-24', 'size': 4088360, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-06-11T03:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are allocated to two parallel groups for intervention and control, evaluated over the same study duration.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-05-31', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Foot Function Index (FFI) Score', 'timeFrame': 'Baseline and 8 weeks after intervention', 'description': 'This measure assesses changes in foot pain, disability, and activity limitation using the Foot Function Index (FFI). Participants complete the FFI questionnaire before and after the intervention period. The score ranges from 0 to 100, with higher scores indicating worse foot function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pes planus', '3D insoles', 'custom made insoles'], 'conditions': ['Pes Planus']}, 'referencesModule': {'references': [{'pmid': '35882078', 'type': 'BACKGROUND', 'citation': 'Daryabor A, Kobayashi T, Saeedi H, Lyons SM, Maeda N, Naimi SS. Effect of 3D printed insoles for people with flatfeet: A systematic review. Assist Technol. 2023 Mar 4;35(2):169-179. doi: 10.1080/10400435.2022.2105438. Epub 2022 Aug 24.'}, {'type': 'BACKGROUND', 'citation': "Yarwindran, M., Sa'aban, N. A., Ibrahim, M., & Periyasamy, R. (2016). Thermoplastic elastomer infill pattern impact on mechanical properties 3D printed customized orthotic insole. ARPN J. Eng. Appl. Sci, 11(7)."}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of custom-designed insoles produced using Computer Numerical Control (CNC) and 3D printers on plantar pressure distribution analysis, foot posture, plantar force distribution, foot pain, and satisfaction in patients diagnosed with pes planus.', 'detailedDescription': 'This randomized controlled trial evaluates the impact of custom-designed insoles, created using Computer Numerical Control (CNC) and 3D printing technologies, on plantar pressure distribution, foot posture, pain, and user satisfaction in individuals with flexible pes planus. The study targets adults aged 18-55, with specific clinical and postural inclusion criteria, and excludes individuals with biomechanical or neurological confounders.\n\nParticipants are randomly assigned to one of two intervention groups using a simple randomization method: one receiving CNC-produced insoles and the other 3D-printed insoles. Assessments are conducted before and after 8 weeks of insole use, employing standardized tools such as the Foot Posture Index, subtalar angle measurement, plantar pressure analysis, and satisfaction/function questionnaires. The primary aim is to explore comparative biomechanical and subjective outcomes to inform best practices in orthotic design and application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged between 18 and 55 years\n* Diagnosed with flexible pes planus (flat feet)\n* No prior use of custom orthotic insoles within the past 6 months\n* Able to walk independently without assistive devices\n* Voluntarily agree to participate and provide informed consent\n\nExclusion Criteria:\n\n* History of lower limb or foot surgery\n* Presence of neurological, rheumatologic, or musculoskeletal disorders affecting gait\n* Presence of severe foot deformities (e.g., rigid pes planus, cavus foot)\n* Use of medications that affect muscle or joint function\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07022093', 'acronym': 'Insoles', 'briefTitle': 'Effects of Custom-Designed 3D-Printed and CAD-CAM Insoles on Individuals With Flexible Flatfoot', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lokman Hekim University'}, 'officialTitle': 'Investigation of the Effects of Custom-Designed 3D-Printed and CAD-CAM-Produced Insoles in Individuals With Flexible Pes Planus', 'orgStudyIdInfo': {'id': '2024211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Custom insoles manufactured using CNC technology', 'description': 'Customised insoles will be produced using CNC technology and delivered based on the analyses of 20 patients with pes planus.', 'interventionNames': ['Device: Custom made insoles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Custom insoles produced using 3D technology', 'description': 'Custom insoles produced using 3D technology will be delivered to 20 patients with pes planus.', 'interventionNames': ['Device: Custom made insoles']}], 'interventions': [{'name': 'Custom made insoles', 'type': 'DEVICE', 'otherNames': ['Insoles'], 'description': "For the production of insoles using the CAD-CAM method; In the production of insoles, medial longitudinal arch support will be added so that the subtalar joints are in a neutral position, and additionally, transverse arch support between 3.5-5 mm, lateral longitudinal arch support between 4-6 mm, and finger-under supports to assist with palmar grip will be designed in three dimensions using the EasyCad modelling interface. Using a Vulcan Computer Numerical Control (CNC) milling machine, the insoles will be machined from Ethylene Vinyl Acetate (EVA) material placed in blocks. After this process, the insoles will be adjusted on the milling machine to fit the patient's shoes.For the production of insoles using the 3D printing method, the Elegoo Neptune 4 Max 3D printer will be used. Using TPU material, medial longitudinal arch support will be added, along with transverse arch support between 3.5-5 mm, lateral longitudinal arch support between 4-6 mm, and finger support to aid palmar grip.", 'armGroupLabels': ['Custom insoles manufactured using CNC technology', 'Custom insoles produced using 3D technology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55139', 'city': 'Samsun', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gözde Kesikbaş Kurt, Orthotist/Prosthetist', 'role': 'CONTACT', 'email': 'gozde.kesikbas@omu.edu.tr', 'phone': '+90 5300407895'}, {'name': 'Nilgün BEK, PhD', 'role': 'CONTACT', 'email': 'nilgun.bek@lokmanhekim.edu.tr', 'phone': '+90 5435530370'}, {'name': 'Nilgün Bek, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ondokuz Mayıs University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'centralContacts': [{'name': 'Gözde Kesikbaş Kurt', 'role': 'CONTACT', 'email': 'gozde.kesikbas@omu.edu.tr', 'phone': '+90 530 040 78 95'}], 'overallOfficials': [{'name': 'Nilgün Bek, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lokman Hekim University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GÖZDE KESİKBAŞ', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Orthotic Prosthetist', 'investigatorFullName': 'GÖZDE KESİKBAŞ', 'investigatorAffiliation': 'Lokman Hekim University'}}}}