Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT05284266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The National Lipedema Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065134', 'term': 'Lipedema'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients are randomized to two different conservative treatment protocols;either standard conservative treatment (SCT) or standard treatment plus additional lymphedema treatment (intermittent pneumatic compression -IPC). After 6 months the effects of the conservative treatment are evaluated. Patients who still want surgery and fulfill the criteria are randomized (1:1) to early (cases(liposuction initiated 6-9 months after inclusion)) or late surgery (controls (liposuction initiated 18-21 months after inclusion)). Randomization to the surgical group is stratified by conservative treatment arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-03-08', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of different conservative treatments on lipedema pain and quality of life and everyday activities for patients with lipedema', 'timeFrame': '6 months after inclusion', 'description': 'Effect of two different conservative treatments strategies on pain and everyday activities (RAND-36)'}, {'measure': 'Adverse effect of liposuction', 'timeFrame': '12 months after last liposuction surgery', 'description': 'Assess possible adverse effects of liposuction'}, {'measure': 'Effect of liposuction on the need for conservative treatment', 'timeFrame': '3 years after last liposuction surgery', 'description': 'Assess whether having undergone liposuction changes the need for conservative treatment.'}], 'primaryOutcomes': [{'measure': 'Effect of liposuction on lipedema pain', 'timeFrame': '12 months after the last liposuction surgery', 'description': 'Assess the effect of liposuction on lipedema pain (Visual Analog Scale (VAS). VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (worst possible pain).'}], 'secondaryOutcomes': [{'measure': 'Effect of liposuction on quality of life and everyday activities for patients with lipedema', 'timeFrame': '12 months after the last liposuction surgery', 'description': 'Assess the effect of liposuction on quality of life and everyday activities (RAND-36)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liposuction', 'Conservative treatment', 'Intermittent pneumatic compression', 'Lipoedema', 'Compression therapy', 'Self management', 'Dietary management'], 'conditions': ['Lipedema']}, 'descriptionModule': {'briefSummary': "Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction.\n\nTreatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking.\n\nThe Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* age 20-65 years\n* significant pain from lipedema\n* lipedema stage 1-2 or localized stage 3\n\nExclusion Criteria:\n\n* Non-fluency in the Norwegian language\n* pregnancy\n* current malignancy\n* previous surgical treatment for lipedema\n* smoking\n* BMI \\> 28\n* serious comorbidities such as cardiac-, pulmonary-, renal disease\n* unwillingness to wear compression garments'}, 'identificationModule': {'nctId': 'NCT05284266', 'briefTitle': 'The National Lipedema Study', 'organization': {'class': 'OTHER', 'fullName': 'Haraldsplass Deaconess Hospital'}, 'officialTitle': 'Surgical Treatment of Lipedema in Norway - a National Multicenter Study', 'orgStudyIdInfo': {'id': '239087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard conservative treatment', 'description': 'Standard conservative treatment consisting of:\n\n* Physical therapy, including compression garment and exercise program\n* Self-care program\n* Individual counseling from a clinical dietician', 'interventionNames': ['Other: Standard conservative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Standard treatment plus additional lymphedema treatment', 'description': 'Standard conservative treatment consisting of:\n\n* Physical therapy, including compression garment and exercise program\n* Self-care program\n* Individual counseling from a clinical dietician Additional lymphedema treatment consisting of intermittent pneumatic compression (IPC)', 'interventionNames': ['Other: Standard conservative treatment with Intermittent Pneumatic Compression (IPC)']}, {'type': 'EXPERIMENTAL', 'label': 'Surgical group: Liposuction', 'description': 'Early liposuction, 6-9 months after inclusion in study.', 'interventionNames': ['Procedure: Liposuction early']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical group: Control', 'description': 'Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group.', 'interventionNames': ['Procedure: Liposuction late']}], 'interventions': [{'name': 'Liposuction early', 'type': 'PROCEDURE', 'description': 'Liposuction 6-9 months after inclusion', 'armGroupLabels': ['Surgical group: Liposuction']}, {'name': 'Liposuction late', 'type': 'PROCEDURE', 'description': 'Liposuction 18-21 months after inclusion', 'armGroupLabels': ['Surgical group: Control']}, {'name': 'Standard conservative treatment', 'type': 'OTHER', 'description': 'Standard Conservative treatment consisiting of:\n\nPhysical therapy, including compression garment and exercise program, Self-care program', 'armGroupLabels': ['Standard conservative treatment']}, {'name': 'Standard conservative treatment with Intermittent Pneumatic Compression (IPC)', 'type': 'OTHER', 'description': 'Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)', 'armGroupLabels': ['Standard treatment plus additional lymphedema treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5009', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haraldsplass Deaconess Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Hildur Skuladottir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haraldsplass Deaconess Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available after publication of outcomes.', 'ipdSharing': 'YES', 'description': 'Data will be available after publication of outcomes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haraldsplass Deaconess Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, {'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'Klinbeforsk', 'class': 'OTHER'}, {'name': 'Helse Vest', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, PhD', 'investigatorFullName': 'Hildur Skuladottir', 'investigatorAffiliation': 'Haraldsplass Deaconess Hospital'}}}}