Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT01594658
Status:
COMPLETED
Last Update Posted:
2012-10-02
First Post:
2011-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venous Ulcer Treatment With Foam Versus Conservative Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-30', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous Ulcer Treatment with Foam Versus Conservative Treatment', 'timeFrame': '6 months', 'description': 'Number of participants with healing of venous ulcer after six months from the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasound-guided foam sclerotherapy; chronic venous ulcers'], 'conditions': ['Venous Ulcer']}, 'referencesModule': {'references': [{'pmid': '20875753', 'type': 'BACKGROUND', 'citation': 'Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg. 2010 Dec;40(6):790-5. doi: 10.1016/j.ejvs.2010.08.011. Epub 2010 Sep 27.'}, {'pmid': '19616975', 'type': 'BACKGROUND', 'citation': 'Darvall KA, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Ultrasound-guided foam sclerotherapy for the treatment of chronic venous ulceration: a preliminary study. Eur J Vasc Endovasc Surg. 2009 Dec;38(6):764-9. doi: 10.1016/j.ejvs.2009.05.027. Epub 2009 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The venous ulcer due to venous insufficiency causes an important morbility to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 6 months to several years. therapeutical alternatives, which can guarantee optimal, fast and persistent in time healings, should be identified.\n\nThe aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration after six months from the intervention, compared with conservative medical handling. The investigators expect that the ultrasound-guided foam sclerotherapy of superficial venous reflux will diminish the time of ulcer healing compared with standard handling.', 'detailedDescription': 'to determine healing rates following ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR) in patients with open (clinical,etiologic, anatomic and pathophysiologic (CEAP) classification, C6) chronic venous ulceration ( CVU) in a randomised clinical trial of foam sclerotherapy for patients with venous ulcer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with C6 by CEAP Clasification', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of Venous Ulcer confirmed by CEAP C6\n* Chronic venous ulcer present for at least 4 weeks\n* Ankle-arm index greater or equal to 0.8 mmHg\n\nExclusion Criteria:\n\n* Severe hepatic, cardiac or pulmonary disease\n* Deep venous thrombosis\n* Active participation in other clinical trials'}, 'identificationModule': {'nctId': 'NCT01594658', 'acronym': 'VUTEF', 'briefTitle': 'Venous Ulcer Treatment With Foam Versus Conservative Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Occidente de Kennedy'}, 'officialTitle': 'Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment', 'orgStudyIdInfo': {'id': 'VUT-3F'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Foam sclerotherapy', 'description': 'This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management', 'interventionNames': ['Procedure: Foam sclerotherapy']}, {'label': 'Conservative', 'description': 'This arm only has medical standard handling (healings performed by the nurse group)', 'interventionNames': ['Procedure: conservative']}], 'interventions': [{'name': 'Foam sclerotherapy', 'type': 'PROCEDURE', 'otherNames': ['(Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016'], 'description': 'Foam application of 1% (Sklerol®, ICV Pharma, Bogota-Colombia), Reg INVIMA: 2002M-0001016, guided by ecography of insufficient superficial veins, doses from 10-40 cc of foam until obtaining endoluminal occlusion of the vein. The patient will rest for 8 minutes and then the leg will be covered with elastic bandage.', 'armGroupLabels': ['Foam sclerotherapy']}, {'name': 'conservative', 'type': 'PROCEDURE', 'otherNames': ['This arm only has medical standard handling'], 'description': 'This arm only has medical standard handling (healings performed by the nurse group)', 'armGroupLabels': ['Conservative']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Hospital Occidente de Kennedy'}], 'overallOfficials': [{'name': 'Miguel A Ramirez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Occidente de Kennedy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Occidente de Kennedy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad El Bosque, Bogotá', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'ernesto nieves', 'investigatorAffiliation': 'Hospital Occidente de Kennedy'}}}}