Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-11 @ 11:45 AM
Study NCT ID:
NCT02655406
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2016-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-06', 'releaseDate': '2023-02-24'}, {'resetDate': '2024-07-26', 'releaseDate': '2024-02-13'}, {'resetDate': '2024-11-22', 'releaseDate': '2024-10-02'}], 'estimatedResultsFirstSubmitDate': '2023-02-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2016-01-12', 'studyFirstSubmitQcDate': '2016-01-12', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's pain score post-procedure using a visual analogue scale (VAS)", 'timeFrame': '10 days', 'description': 'Pain score'}], 'secondaryOutcomes': [{'measure': 'Aberdeen Varicose Vein Questionnaire (AVVQ) score', 'timeFrame': '6 months', 'description': 'Disease-specific quality of life score'}, {'measure': 'Chronic venous insufficiency (CIVIQ) score', 'timeFrame': '6 months', 'description': 'Disease-specific quality of life score'}, {'measure': "EuroQol's EQ-5D", 'timeFrame': '6 months', 'description': 'Generic quality of life score'}, {'measure': 'Venous clinical severity score (VCSS)', 'timeFrame': '6 months', 'description': 'Clinical'}, {'measure': 'Occlusion rate', 'timeFrame': '6 months', 'description': 'Occlusion rates will be assessed based on a pre-agreed scale'}, {'measure': 'Degree of phlebitis', 'timeFrame': '6 months', 'description': 'Extent of phlebitis will be recorded using a scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Foam sclerotherapy', 'Compression'], 'conditions': ['Varicose Veins']}, 'descriptionModule': {'briefSummary': 'This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either the compression group (group A) or the no compression group (group B).\n\nThe pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.', 'detailedDescription': "This will be a randomised clinical trial looking at the impact of wearing or not wearing compression stocking following endovenous ablation using foam sclerotherapy.\n\nPatients will be randomised to group A (compression) and group B (no compression).\n\nTarget Population Patients referred to the Imperial College NHS Trust for treatment of symptomatic varicose veins will be recruited if they are found to have varicose veins suitable for foam sclerotherapy on colour duplex scan.\n\nIntervention\n\nPatients will be randomised to have compression (group A) or no compression (group B). This will be done by using an online randomisation software (Sealed Envelope Ltd).\n\nThe compression therapy used will be Class II compression stockings. The treatment offered will be foam sclerotherapy of varicose veins using either Polidocanol or Sodium Tetradecyl Sulphate (STS) with the concentration used left to the discretion of the clinician.\n\nPatients randomised to group A will be asked to wear compression stockings for 1 week.\n\nPatients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards.\n\nAt baseline, patients will be asked to fill validated quality of life questionnaires (EQ-5D, AVVQ and CIVIQ) and will have their clinical scores assessed using a validated scoring system (CEAP and VCSS). On discharge after their varicose vein intervention, they will then be provided with a diary to record their post-procedural pain every day for 10 days using a validated visual analogue scale (VAS) as well as to record when they return to their normal activities and are back to work. They will also be asked to attend a follow-up in 2 weeks and at 6 months.\n\nPatients' GP will also be sent a letter to inform them of their patient's participation in the study.\n\nFollow-up\n\nPatients will be followed up in the outpatient clinic at 2 weeks and 6 months.\n\nFollow-up at 2 Weeks\n\nAt the 2 weeks' follow-up, the diary containing details of the pain scores and how soon patients were able to return to normal activities/work will be collected. In addition, patients will be asked about any phlebitis they have had in the two weeks after their procedure and how compliant they have been with the compression. They will be examined and the Venous Clinical Severity Score (VCSS) will be recorded. They will also be asked to fill in the EQ-5D, AVVQ and CIVIQ scores.\n\nFollow-up at 6 Months\n\nAt the 6 months follow-up, patients will be examined and their VCSS will be recorded. They will also be asked to fill the EQ-5D, AVVQ and the CIVIQ scores. They will have a venous Duplex scan to determine occlusion of the treated vein.\n\nSample Size and Study Duration\n\nWe estimated the sample size needed to observe a difference of at least 10mm in the VAS score, with a standard deviation of 20mm. With power at 80% and 5% significance equivalence, we would need to recruit 128 patients (64 per group) to show a difference.\n\nPrevious studies looking at compression stockings have shown drop out rates close to 37% at 3 months10. Therefore, if we estimate a drop out rate of about 40% by 6 months, we would need to recruit at least 180 patients. If we recruit at least 2 patients per week, this will be approximately a total of 208 patients that could potentially be randomised over the course of two years.\n\nWith 6 months follow-up, therefore, the study will be running for 24 months with a target recruitment of 180 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 18 years of age\n* Varicose veins suitable for foam sclerotherapy\n\nExclusion Criteria:\n\n* Allergic to sclerosant\n* Current DVT\n* Arterial disease (ABPI\\<0.8)\n* Patients unable to wear compression stockings\n* Patients who are unwilling to participate\n* Inability or unwillingness to complete questionnaires\n* Inability to attend follow-up appointments'}, 'identificationModule': {'nctId': 'NCT02655406', 'acronym': 'CONFETTI', 'briefTitle': 'COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)', 'orgStudyIdInfo': {'id': '15/NE/0314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Compression stockings', 'description': 'Patients randomised to group A will be asked to wear compression stockings for 1 week', 'interventionNames': ['Other: Class 2 compression stockings']}, {'type': 'NO_INTERVENTION', 'label': 'No compression', 'description': 'Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards'}], 'interventions': [{'name': 'Class 2 compression stockings', 'type': 'OTHER', 'armGroupLabels': ['Compression stockings']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W6 8RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Roshan Bootun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-02-24', 'type': 'RELEASE'}, {'date': '2023-12-06', 'type': 'RESET'}, {'date': '2024-02-13', 'type': 'RELEASE'}, {'date': '2024-07-26', 'type': 'RESET'}, {'date': '2024-10-02', 'type': 'RELEASE'}, {'date': '2024-11-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}