Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT01372020
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2011-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Therapy in Venous Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-21', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'the subjects will be followed for a period of 4 weeks.', 'description': 'Pain assessment will be performed by the Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'ulcer area', 'timeFrame': 'the patients will be folloed for the 4-weeks.', 'description': 'the ulcer area will be measured by the planimetry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Varicose ulcer', 'wound healing', 'electrical stimulation'], 'conditions': ['Chronic Venous Insufficiency']}, 'referencesModule': {'references': [{'pmid': '3893385', 'type': 'RESULT', 'citation': 'Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.'}, {'pmid': '22990161', 'type': 'DERIVED', 'citation': 'Korelo RI, Valderramas S, Ternoski B, Medeiros DS, Andres LF, Adolph SM. Microcurrent application as analgesic treatment in venous ulcers: a pilot study. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):753-60. doi: 10.1590/s0104-11692012000400016. English, Portuguese, Spanish.'}]}, 'descriptionModule': {'briefSummary': 'The use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain.\n\nThe aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.', 'detailedDescription': 'The aim was to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency. In a simple-blind controlled clinical study, 20 subjects with venous ulcers with age over 50 years will be divided in two groups:neuromuscular electrical stimulation(n=10) and control group (n=10). Pain (by Visual Analogue Scale) and the ulcer area (by planimetry on graph paper and the software ImageJ ®) were measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of both genders\n* aged over 50 years\n* sedentary and with clinical diagnosis of chronic venous insufficiency with ulcer in lower limbs will be included\n\nExclusion Criteria:\n\n* Subjects with pacemakers\n* diabetes\n* uncontrolled hypertension\n* osteomyelitis and pain of unknown origin\n* unable to walk or make use of drugs that acted directly on the healing process will be excluded'}, 'identificationModule': {'nctId': 'NCT01372020', 'briefTitle': 'Neuromuscular Electrical Therapy in Venous Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade Evangelica do Parana'}, 'officialTitle': 'The Effect of Neuromuscular Electrical Therapy on Pain in Patients With Venous Ulcers: a Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'fepar-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'control group', 'interventionNames': ['Other: neuromuscular electrical stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'neuromuscular electrical therapy', 'interventionNames': ['Other: neuromuscular electrical stimulation']}], 'interventions': [{'name': 'neuromuscular electrical stimulation', 'type': 'OTHER', 'otherNames': ['intervention group'], 'description': 'The application technique used will be bipolar, with electrodes of the type metal-tipped pen. The electrodes will be placed at the outer edges of the ulcer, on opposite sides of the same and the estimated time of 1 minute at each point. All the edge of the ulcer will be bypassed, thereby separating the injections every 1 cm, returning to the starting point at the end of the application. To ensure that the entire edge of the ulcer to receive the stimulation, the end points of the application, the application will be made for another minute sliding the pen around the whole edge. Thus the application time will be directly proportional to the ulcer area. The subjects will be received 10 applications, three times a week for a period of 4 weeks.', 'armGroupLabels': ['control group', 'neuromuscular electrical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Faculdade Dom Bosco', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}], 'overallOfficials': [{'name': 'Korelo Raciele, M.sC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Facukdade Dom Bosco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade Evangelica do Parana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Silvia Valderramas', 'investigatorFullName': 'Silvia Valderramas', 'investigatorAffiliation': 'Faculdade Evangelica do Parana'}}}}