MedTrace Logo

Venous Ulcer Treatment With Foam Versus Conservative Treatment

NCT01594658 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2012-10-02

No results posted yet for this study

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.

Conditions

  • Venous Ulcer

Interventions

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.

PROCEDURE

conservative

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

Sponsors & Collaborators

  • Universidad El Bosque, Bogotá

    collaborator OTHER

  • Hospital Occidente de Kennedy

    lead OTHER

Principal Investigators

  • Miguel A Ramirez, MD · Hospital Occidente de Kennedy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29
Completion
2012-09-30

Countries

  • Colombia

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01594658 on ClinicalTrials.gov