Venous Ulcer Treatment With Foam Versus Conservative Treatment

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01594658

Acronym

VUTEF

Enrollment

Registered

2012-05-09

Start date

2011-07-31

Completion date

2012-09-30

Last updated

2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Ulcer

Keywords

Ultrasound-guided foam sclerotherapy; chronic venous ulcers

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.

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

Interventions

PROCEDUREFoam 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.

PROCEDUREconservative

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026