Venous Ulcer Treatment With Foam Versus Conservative Treatment

NCT01594658 | Completed

• 1 other identifier: VUT-3F
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Ulcer

Keywords

Ultrasound-guided foam sclerotherapy; chronic venous ulcers

Outcome Measures

Primary Outcomes (1)

• Venous Ulcer Treatment with Foam Versus Conservative Treatment

  Number of participants with healing of venous ulcer after six months from the intervention.

  6 months

Study Arms (2)

Foam sclerotherapy

This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management

Procedure: Foam sclerotherapy

Conservative

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

Procedure: conservative

Interventions

Foam sclerotherapy PROCEDURE

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.

Also known as: (Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016

Foam sclerotherapy

conservative PROCEDURE

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

Also known as: This arm only has medical standard handling

Conservative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with C6 by CEAP Clasification

You may qualify if:

• 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

You may not qualify if:

• Severe hepatic, cardiac or pulmonary disease
• Deep venous thrombosis
• Active participation in other clinical trials

Sponsors & Collaborators

• Hospital Occidente de Kennedy: lead
• Universidad El Bosque, Bogotá: collaborator

Study Sites (1)

Hospital Occidente de Kennedy

Bogota, Cundinamarca, Colombia

Location

Related Publications (2)

• 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.

  PMID: 20875753 BACKGROUND

• 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.

  PMID: 19616975 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Miguel A Ramirez, MD

  Hospital Occidente de Kennedy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: May 9, 2012
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

CO (1)