Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)

Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment

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.

Study Overview

• Status: Completed
• Conditions: Venous Ulcer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Hospital Occidente de Kennedy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with C6 by CEAP Clasification

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: (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 Names: This arm only has medical standard handling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous Ulcer Treatment with Foam Versus Conservative Treatment	Number of participants with healing of venous ulcer after six months from the intervention.	6 months

Collaborators and Investigators

• Sponsor: Hospital Occidente de Kennedy
• Collaborators: Universidad El Bosque, Bogotá
• Investigators: Study Director: Miguel A Ramirez, MD, Hospital Occidente de Kennedy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: September 30, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Ultrasound-guided foam sclerotherapy; chronic venous ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer
• Other Study ID Numbers: VUT-3F