Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT03512912
Status:
UNKNOWN
Last Update Posted:
2018-05-07
First Post:
2018-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking distance', 'timeFrame': '6 months', 'description': 'Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Intermittent Claudication', 'Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.', 'detailedDescription': 'The investigators conduct a prospective mono-centric trial on all patient with peripheral arterial disease with intermittent claudication that receive supervised exercise therapy (SET) and additional transcutaneous electric stimulation (TES) of the calf muscle. SET program consists in once weekly walking training for 75 min under supervision of a professional trainer. Patients are encouraged to continue the training modules at home. TES is performed using the mobile "Veinoplus arterial" device (AdRem Technology, France) on a daily base for 60-120 min at home. Patient outcome will be compared to the retrospectively analyzed results of patients, that received the same SET program alone in the past.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of our department of vascular end endovascular surgery, university hospital Dusseldorf with the above mentioned inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intermittent claudication due to peripheral arterial disease\n* ankle brachial index \\</=0.9\n* occlusion or stenosis of the superficial femoral artery\n\nExclusion Criteria:\n\n* rest pain or peripheral arterial lesions\n* contraindications for supervised walking therapy\n* non-vascular conditions that limit patients´ walking ability\n* patients that have already received supervised walking therapy\n* occlusion of the deep femoral artery\n* occlusion or high-grade stenoses of the iliac arteries\n* stroke in the last 12 months\n* premenopausal women\n* diabetes mellitus, dialysis, sclerodermia and other conditions that impair leg perfusion\n* active cilostazol therapy or alprostadil-infusion in the last 3 months\n* pacemaker, defibrillator systems, life vest\n* visible muscle contraction is not achieved without pain'}, 'identificationModule': {'nctId': 'NCT03512912', 'acronym': 'TESLA', 'briefTitle': 'Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Transcutaneous Electrostimulation of the Calf Muscle and Supervised Walking Therapy for Intermittent cLAudication', 'orgStudyIdInfo': {'id': 'TESLA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transcutaneous electrical calf muscle stimulation + supervised walking therapy', 'type': 'DEVICE', 'description': 'transcutaneous electrical calf muscle stimulation + supervised walking therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philip Düppers, MD', 'role': 'CONTACT', 'email': 'philip.dueppers@med.uni-duesseldorf.de', 'phone': '+492118117090'}], 'facility': 'University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Philip Düppers, MD', 'role': 'CONTACT', 'email': 'philip.dueppers@med.uni-duesseldorf.de', 'phone': '+492118117090'}], 'overallOfficials': [{'name': 'Philip Düppers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Vascular and Endovascular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Dr. Philip Düppers', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}