Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-04-29 @ 6:26 PM
Study NCT ID:
NCT02432859
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2015-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)', 'timeFrame': 'Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Wound surface area(cm2)', 'timeFrame': 'Change from Baseline in wound surface area at 2 and 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Foot']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.', 'detailedDescription': '30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) was measured at 1st, 6th, and 12th session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic diabetic foot ulcer\n* Wagner classification DFU 2\n* 0.5\\<ABI\\<0.9\n* Mild to moderate diabetic neuropathy\n\nExclusion Criteria:\n\n* Fracture in a lower limb\n* A severe infection\n* A malignancy\n* Kidney failure\n* Skin diseases\n* Osteomyelitis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02432859', 'briefTitle': 'Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Tarbiat Modarres University'}, 'officialTitle': 'The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer', 'orgStudyIdInfo': {'id': 'D52/2509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Electrical stimulation', 'description': 'In the electrical stimulation group, group who received direct current ES at sensory threshold intensity for 1 h/day, 3 days/week, for 4 weeks (12 sessions)', 'interventionNames': ['Procedure: Electrical Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero', 'interventionNames': ['Procedure: Placebo']}], 'interventions': [{'name': 'Electrical Stimulation', 'type': 'PROCEDURE', 'otherNames': ['Direct current ES'], 'description': 'Direct current with sensory intensity for one hour', 'armGroupLabels': ['Electrical stimulation']}, {'name': 'Placebo', 'type': 'PROCEDURE', 'otherNames': ['Placebo Direct current ES'], 'description': 'Direct current with zero intensity for one hour', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Tarbiat Modares University', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Giti Torkaman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tarbiat Modarres University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity', 'investigatorFullName': 'giti torkaman', 'investigatorAffiliation': 'Tarbiat Modarres University'}}}}