Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05310435
Status:
TERMINATED
Last Update Posted:
2025-06-04
First Post:
2022-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-14', 'size': 28775, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-03-03T13:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg volume measured with ESD (ml)', 'timeFrame': '1 minute', 'description': 'Obtained with the Edema Stocking device'}, {'measure': 'Leg volume measured with WDV (ml)', 'timeFrame': '1 minute', 'description': 'Obtained with water displacement volumetry'}, {'measure': 'Leg circumference measured with tape measure (mm)', 'timeFrame': '1 minute', 'description': 'Obtained with tape measure'}, {'measure': 'Leg circumference measured with ESD (mm)', 'timeFrame': '60 minutes', 'description': 'Obtained with the Edema Stocking Device'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lower leg edema', 'Equivalence study', 'Leg volume'], 'conditions': ['Edema Leg']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate a prototype of an intelligent stocking (Edema Stocking Device \\[ESD\\]), consisting of two stretch sensitive sensors, as a new method for continuously lower leg volume monitoring. The study is a scientific evaluation of the ESD compared with water displacement volumetry and tape measure.', 'detailedDescription': 'Background:\n\nBalance of body fluids is strictly regulated within a narrow range and is controlled by water movement between the interstitial compartment and the capillaries. An unnatural balance between the two compartments can be seen in several diseases, leading to a net filtration out of the vascular space, resulting in the formation of edema. Monitoring of edema formation represents a unique way of evaluating the degree of the underlying disease and effect of treatment. Numerous different methods can be used to quantify leg volume. However, no current method provides continuous quantitative assessment. The feasibility of continuous lower leg measuring using an intelligent stocking was hypothesized.\n\nThe aim of the study was to evaluate the Edema Stocking device (ESD) as a tool for continuous quantification of edema compared with water displacement volumetry (WDV) and tape measure.\n\nMaterials and methods:\n\nStudy design: Non-randomized equivalence study. Experimental comparison study of new method compared to golden standard.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women, 20-40 years, located to the Central Region of Denmark, admitted to Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.', 'genderDescription': 'Pregnant women', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Edema of the lower legs.\n* Between 20-18 years.\n* Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.\n\nExclusion Criteria:\n\n* Length of lower leg of more than 34,0 cm (measured from floor to knee).'}, 'identificationModule': {'nctId': 'NCT05310435', 'briefTitle': 'A New Intelligent Stocking for Quantification of Edema in the Lower Limbs', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A New Intelligent Stocking for Quantification of Edema in the Lower Limbs', 'orgStudyIdInfo': {'id': '1-10-72-143-17'}, 'secondaryIdInfos': [{'id': '2017084027', 'type': 'OTHER', 'domain': 'Danish Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women with lower leg edema', 'description': 'Pregnant women with clinical lower leg edema measured two times with Edema Stocking device, two times with water displacement volumetry and two with tape measure each day for three days.', 'interventionNames': ['Device: Single volume measurement with ESD', 'Device: Single volume measurement with WDV', 'Device: Single circumference measurement with tape measure', 'Device: Continuous volume measurement with ESD']}], 'interventions': [{'name': 'Single volume measurement with ESD', 'type': 'DEVICE', 'description': 'Single volume measurement with Edema Stocking device', 'armGroupLabels': ['Pregnant women with lower leg edema']}, {'name': 'Single volume measurement with WDV', 'type': 'DEVICE', 'description': 'Single volume measurement with water displacement volumetry method', 'armGroupLabels': ['Pregnant women with lower leg edema']}, {'name': 'Single circumference measurement with tape measure', 'type': 'DEVICE', 'description': 'Single circumference measurement with tape measure', 'armGroupLabels': ['Pregnant women with lower leg edema']}, {'name': 'Continuous volume measurement with ESD', 'type': 'DEVICE', 'description': 'Continuous volume measurement with Edema Stocking device', 'armGroupLabels': ['Pregnant women with lower leg edema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department og Gynaecology and Obstetrics, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Olav B Petersen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ohmatex ApS', 'class': 'UNKNOWN'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project manager', 'investigatorFullName': 'Alexander Emil Kaspersen', 'investigatorAffiliation': 'University of Aarhus'}}}}