Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06696118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2024-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electromagnetic Transduction Therapy on Osteoarthritis in the Foot and Ankle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) for Pain', 'timeFrame': 'Baseline, 3 weeks, 3 months, 6 months', 'description': 'The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.'}, {'measure': 'Foot and Ankle Ability Measure (FAAM)', 'timeFrame': 'Baseline, 3 weeks, 3 months, 6 months', 'description': "The Foot and Ankle Ability Measure (FAAM) ADL is a 21-item self-report questionnaire measuring Activities of Daily Living. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 are reported in percentage scores. Higher scores represent higher levels of function, with 100% representing no dysfunction."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Electromagnetic Transduction Therapy'], 'conditions': ['Osteoarthritis Ankle', 'Osteoarthritis Foot']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Electromagnetic Transduction Therapy (EMTT) is a viable treatment option in patients with osteoarthritis of the foot and/or ankle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs.\n\nExclusion Criteria:\n\n• Pacemaker, active cancer, shrapnel, metal in eye, implantable devices that are not compatible with MRIs, concurrent foot or ankle condition or injury, prior foot or ankle surgery for osteoarthritis, steroid, platelet rich plasma, or hyaluronic acid injection within 2 months of the treatment.'}, 'identificationModule': {'nctId': 'NCT06696118', 'briefTitle': 'Electromagnetic Transduction Therapy on Osteoarthritis in the Foot and Ankle', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Electromagnetic Transduction Therapy (EMTT) on Mid-foot Osteoarthritis: A Pilot Study', 'orgStudyIdInfo': {'id': '24-002661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mid-foot osteoarthritis', 'interventionNames': ['Device: Electromagnetic Transduction Therapy (EMTT)']}], 'interventions': [{'name': 'Electromagnetic Transduction Therapy (EMTT)', 'type': 'DEVICE', 'description': 'Subjects will be treated with Electromagnetic Transduction Therapy (EMTT) using the Curamedix MAGNETOLITH device. Treatments will be administered twice per week, for four weeks. Each treatment will have the following settings: level 8, 8Hz, and 10,000 pulses andwill take about 15 to 20 minutes. Treatments will be spaced 2-3 days apart.', 'armGroupLabels': ['Mid-foot osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Elizabeth Bondi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elizabeth Bondi', 'investigatorAffiliation': 'Mayo Clinic'}}}}