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Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)

This study has been completed.
Sponsor:
Collaborator:
Universidad El Bosque, Bogotá
Information provided by (Responsible Party):
ernesto nieves, Hospital Occidente de Kennedy
ClinicalTrials.gov Identifier:
NCT01594658
First received: July 18, 2011
Last updated: September 30, 2012
Last verified: September 2012
History of Changes
  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 Hospital Occidente de Kennedy:

Primary Outcome Measures:
  • Venous Ulcer Treatment with Foam Versus Conservative Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Research Committee Web Page  This link exits the ClinicalTrials.gov site
Web Page hospital  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: ernesto nieves, medical doctor, Hospital Occidente de Kennedy
ClinicalTrials.gov Identifier: NCT01594658     History of Changes
Other Study ID Numbers: VUT-3F
Study First Received: July 18, 2011
Last Updated: September 30, 2012
Health Authority: Colombia: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013