Venous Ulcer Treatment With Foam Versus Conservative Treatment

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Venous Ulcer

Intervention / Treatment
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* Procedure: Foam sclerotherapy
* Procedure: conservative


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Foam sclerotherapy<br>This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management | Procedure: Foam sclerotherapy<br>* 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.<br>* Other names: (Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016;|
| Conservative<br>This arm only has medical standard handling (healings performed by the nurse group) | Procedure: conservative<br>* This arm only has medical standard handling (healings performed by the nurse group)<br>* Other names: This arm only has medical standard handling;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound-guided foam sclerotherapy; chronic venous ulcers