Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT04757766
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-02-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'olga.linnik@servier.com', 'phone': '8-495-93707-00', 'title': 'olga linnik', 'organization': 'Servier'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).', 'otherNumAtRisk': 349, 'deathsNumAtRisk': 349, 'otherNumAffected': 1, 'seriousNumAtRisk': 349, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'exacerbation of chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v.25.1.'}], 'frequencyThreshold': '0.29'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).'}], 'classes': [{'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': '% of patients with complete healing of the reference venous ulcer after 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Eeffectiveness of Systemic Pharmacotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).'}], 'classes': [{'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': '% of patients with reduction in the CVD clinical class by CEAP classification', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Healing of the Reference Venous Ulcers #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': '% of patients with healed reference VU after 3 months of treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Healing of the Reference Venous Ulcers at Visit 3 vs Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.02', 'spread': '4.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'change in the area of reference VU in cm² (measured with LesionMeter application)', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '349'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '349'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '179', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.95', 'spread': '12.71', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '233', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '116', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '349', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'patients with venous ulcers (CEAP classes C6) treated in daily clinical practice\n\nThe reference VU must meet the following criteria:\n\n* area is no less than 5 cm² but no more than 30 cm²,\n* phase 2 or 3 of the wound healing process,\n* location on the medial aspect of lower third of leg.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-23', 'size': 586206, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-17T03:37', 'hasProtocol': True}, {'date': '2020-12-23', 'size': 186759, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-17T03:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2021-02-12', 'resultsFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-17', 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy', 'timeFrame': '6 months', 'description': '% of patients with complete healing of the reference venous ulcer after 6 months'}, {'measure': 'Eeffectiveness of Systemic Pharmacotherapy', 'timeFrame': '6 months', 'description': '% of patients with reduction in the CVD clinical class by CEAP classification'}], 'secondaryOutcomes': [{'measure': 'Healing of the Reference Venous Ulcers #1', 'timeFrame': '3 months', 'description': '% of patients with healed reference VU after 3 months of treatment'}, {'measure': 'Healing of the Reference Venous Ulcers at Visit 3 vs Baseline', 'timeFrame': '6 months', 'description': 'change in the area of reference VU in cm² (measured with LesionMeter application)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Venous Insufficiency']}, 'descriptionModule': {'briefSummary': 'The VAP-PRO-C6 is a Russian multicenter observational program to be implemented at the routine visits and assessments. The program will include patients with chronic venous disease of CEAP classes C6. This program is planned to be carried out in Russia in 2021-2022.', 'detailedDescription': 'Aim of the program is to describe effectiveness and tolerability of systemic pharmacotherapy as a part of combination therapy and its effect on the overall treatment outcomes in patients with venous ulcers (CEAP classes C6) treated in real clinical settings.\n\nThe planned number of patients is 350.\n\nThe inclusion period lasts for 6 months. The treatment will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation. The following objective methods will be used to assess the changes in the skin condition:\n\n* measurement of the area of reference ulcer (using LesionMeter\\*) before and after the treatment;\n* changes in status localis.\n* The presence and location of venous reflux and/or occlusion. The study does not implicate any intervention to routine management of patients with chronic venous disease (CVD). In particular, in this study the parameters that are usually evaluated during the examination of patients with classes C6 CVD (CEAP) will be recorded. Special attention will be paid to evaluating changes of the area of referent VU using objective methods (measuring ulcer area using LesionMeter, time to ulcer healing).\n\n * LesionMeter is a generally available tool for measuring the venous ulcer area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with venous ulcers (CEAP classes C6) treated in real clinical settings', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CVD documented by venous DUS\n* Age over 18 years\n* Written informed consent is provided\n* No treatment with venoactive drugs within 4 weeks prior to inclusion in the study\n* Presence of a primary /active venous ulcer (class C6/ CEAP) that meets criteria for the referent ulcer\n* No surgical intervention or procedure (including sclerotherapy) for CVD is planned\n\nExclusion Criteria:\n\n* Withdrawal of the informed consent\n* Pregnancy or willingness to become pregnant within at least 2 months after the end of the study\n* Indications for surgery (including sclerotherapy)\n* Serious violation or non adherence to the prescribed therapy/ regimen\n* Use of prohibited drugs that can cause edema of lower extremities (calcium channel blockers, hormonal agents, NSAIDs, etc.)'}, 'identificationModule': {'nctId': 'NCT04757766', 'acronym': 'VAP-PRO-C6', 'briefTitle': 'VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier Russia'}, 'officialTitle': 'VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy and Their Effect on the Overall Treatment Outcomes in Patients With Chronic Venous Diseases of CEAP Classes C6 in Real Clinical Practice', 'orgStudyIdInfo': {'id': 'IC4-05682-066-RUS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'in daily everyday routine practice', 'type': 'DRUG', 'description': 'The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'The first Phlebological Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Servier Russia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}