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Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01594658

First Posted: May 9, 2012

Last Update Posted: October 2, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Universidad El Bosque, Bogotá

Information provided by (Responsible Party):

ernesto nieves, Hospital Occidente de Kennedy

Purpose

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.

The 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.

Condition	Intervention
Venous Ulcer	Procedure: Foam sclerotherapy Procedure: conservative


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment

Further study details as provided by ernesto nieves, Hospital Occidente de Kennedy:

Primary Outcome Measures:

Venous Ulcer Treatment with Foam Versus Conservative Treatment [ Time Frame: 6 months ]
Number of participants with healing of venous ulcer after six months from the intervention.


Enrollment:	46
Study Start Date:	July 2011
Study Completion Date:	September 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Foam sclerotherapy This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management	Procedure: Foam sclerotherapy 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. Other Name: (Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016
Conservative This arm only has medical standard handling (healings performed by the nurse group)	Procedure: conservative This arm only has medical standard handling (healings performed by the nurse group) Other Name: This arm only has medical standard handling

Groups/Cohorts

Assigned Interventions

Foam sclerotherapy

This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management

Procedure: Foam sclerotherapy

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.

Other Name: (Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016

Conservative

This arm only has medical standard handling (healings performed by the nurse group)

Procedure: conservative

This arm only has medical standard handling (healings performed by the nurse group)

Other Name: This arm only has medical standard handling

Detailed Description:

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with C6 by CEAP Clasification

Criteria

Inclusion Criteria:

Presence of Venous Ulcer confirmed by CEAP C6
Chronic venous ulcer present for at least 4 weeks
Ankle-arm index greater or equal to 0.8 mmHg

Exclusion Criteria:

Severe hepatic, cardiac or pulmonary disease
Deep venous thrombosis
Active participation in other clinical trials

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594658

Locations


Colombia
Hospital Occidente de Kennedy
Bogota, Cundinamarca, Colombia

Sponsors and Collaborators

Hospital Occidente de Kennedy

Universidad El Bosque, Bogotá

Investigators


Study Director:	Miguel A Ramirez, MD	Hospital Occidente de Kennedy

More Information

Additional Information:

Web Page hospital This link exits the ClinicalTrials.gov site

Publications:

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.

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.


Responsible Party:	ernesto nieves, medical doctor, Hospital Occidente de Kennedy
ClinicalTrials.gov Identifier:	NCT01594658 History of Changes
Other Study ID Numbers:	VUT-3F
First Submitted:	July 18, 2011
First Posted:	May 9, 2012
Last Update Posted:	October 2, 2012
Last Verified:	September 2012

Keywords provided by ernesto nieves, Hospital Occidente de Kennedy:


Ultrasound-guided foam sclerotherapy; chronic venous ulcers

Additional relevant MeSH terms:


Ulcer Varicose Ulcer Pathologic Processes Varicose Veins Vascular Diseases	Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases

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