Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 4:24 AM
Study NCT ID:
NCT05185193
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2021-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Circumference(the lower calf at 7 cm proximal to the midpoint of the medial malleolus, behind the medial malleolus, and the dorsum of the foot)', 'timeFrame': 'Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group', 'description': 'Circumference was measured using a tape measure at three anatomical locations.'}], 'secondaryOutcomes': [{'measure': 'Change of Volume', 'timeFrame': 'Changes of volume before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group', 'description': 'The leg volume test is measured using Volumeters (Deluxe Foot) of Jeongdo BNP Co., Ltd. in Korea.\n\nMeasure using the principle of overflowing, fill a cylinder with a diameter of 30cm and a height of 30cm with water, put one leg in the cylinder with the ankle bent at 90 degrees, and take the overflowing water and measure the amount in ml.'}, {'measure': 'digital infrared thermal imaging(DITI)', 'timeFrame': 'Changes of body heat before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group', 'description': "Measure the subject's leg body heat using DITI."}, {'measure': 'Visual analog scale(VAS)', 'timeFrame': 'Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group', 'description': 'Discomfort VAS is used to measure the degree of discomfort for lower extremity edema after application of the device. And 0 indicates no discomfort at all, and 10 indicates the most severe discomfort imaginable.'}, {'measure': 'weight', 'timeFrame': 'Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group', 'description': "Measure the participant's weight (kg) using a scale."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the efficacy and safety of the radiofrequency stimulation compared to the sham stimulation in reducing lower extremity edema in adult women with idiopathic edema.', 'detailedDescription': 'In this study, based on the characteristics of radiofrequency, it was hypothesized that radiofrequency could have an effect on the reduction of lower extremity edema and prevention of fatigue. The occurrence of edema is interpreted as a problem that blood circulation is not smooth due to increased inflow of body fluid, and therefore the degree of edema is also used as an indicator of blood circulation.\n\nTherefore, in this study, based on the principle that radiofrequency promotes phosphorylation and blood circulation, the purpose of this study is to investigate whether radiofrequency treatment is effective in reducing edema of the lower extremities and changing body heat in the lower extremities compared to the gastric stimulation device through exploratory research.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women between the ages of 19 and 72\n2. Those who are not likely to menstruate during the trial treatment period (3 days) (females within 8 to 18 days after the onset of menstruation)\n3. Those who meet the diagnostic criteria for idiopathic edema (McKendry criteria score of 15 or higher)\n4. Those who show a weight change of 1.4 kg or more between morning and night measurements\n5. Those who have a difference of 1cm or more from the ankle or 2cm or more from the calf when measuring the circumference in the morning and evening\n6. Those who voluntarily agree to participate in this clinical trial and sign the consent form\n\nExclusion Criteria:\n\n1. In the case of using a heart rate control device such as a metallic substance in the human body\n2. During menstruation or if there is a possibility of pregnancy\n3. If you have heart disease\n4. If you have liver or kidney disease\n5. If there is bleeding or internal bleeding from wounds or surgery\n6. For hypertensive patients\n7. For epilepsy patients\n8. If you are taking weight loss or health-related drugs/health functional foods\n9. In the case where it is judged by the principal investigator that participation in this study is not appropriate'}, 'identificationModule': {'nctId': 'NCT05185193', 'briefTitle': 'Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency in Adult Women With Idiopathic Edema: Blinded, Cross-over, Pilot Study', 'orgStudyIdInfo': {'id': '03-2020-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'radiofrequency stimulation', 'description': 'Participants received radiofrequency stimulation three times a day for 30 minutes once a day. After the end of the first session intervention, there was a washout period and the next intervention was started at a time point when the next menstruation was not likely (8-18 days after the onset of menstruation).', 'interventionNames': ['Device: radiofrequency']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham stimulation', 'description': 'Participants received a sham stimulation similar to a radiofrequency stimulation three times a day for 30 minutes once a day. After the end of the first session intervention, there was a washout period and the next intervention was started at a time point when the next menstruation was not likely (8-18 days after the onset of menstruation).', 'interventionNames': ['Device: sham stimulation']}], 'interventions': [{'name': 'radiofrequency', 'type': 'DEVICE', 'otherNames': ['high frequency'], 'description': 'Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times', 'armGroupLabels': ['radiofrequency stimulation']}, {'name': 'sham stimulation', 'type': 'DEVICE', 'description': 'The appearance is the same as the medical device for clinical trials, and when applied, the sound and the amount of light visible from the outside are designed to be the same as the medical device for clinical trials. The external light was the same, and only the high frequency that stimulates the dermis was blocked. The sham device was applied once a day for 30 minutes, a total of 3 times.', 'armGroupLabels': ['sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50610', 'city': 'Gyeongsang', 'state': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan national university Yangsan Hospital', 'geoPoint': {'lat': 35.3164, 'lon': 126.93455}}], 'overallOfficials': [{'name': 'Young-Il Shin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yong-il Shin', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}