Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)

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.
 
ClinicalTrials.gov Identifier: NCT01594658
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : October 2, 2012
Sponsor:
Collaborator:
Universidad El Bosque, Bogotá
Information provided by (Responsible Party):
ernesto nieves, Hospital Occidente de Kennedy

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment
Venous Ulcer Procedure: Foam sclerotherapy Procedure: conservative

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
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 46 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : September 2012
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Colombia
Hospital Occidente de Kennedy
Bogota, Cundinamarca, Colombia
Sponsors and Collaborators
Hospital Occidente de Kennedy
Universidad El Bosque, Bogotá
Investigators
Layout table for investigator information
Study Director: Miguel A Ramirez, MD Hospital Occidente de Kennedy
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: ernesto nieves, medical doctor, Hospital Occidente de Kennedy
ClinicalTrials.gov Identifier: NCT01594658    
Other Study ID Numbers: VUT-3F
First Posted: May 9, 2012    Key Record Dates
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:
Layout table for MeSH terms
Varicose Ulcer
Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
 Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases