Venous Ulcer Treatment With Foam Versus Conservative Treatment

Completed

• Conditions: Venous Ulcer
• Interventions: Procedure: conservative; Procedure: Foam sclerotherapy

• Registration Number: NCT01594658
• Lead Sponsor: Hospital Occidente de Kennedy

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

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Primary Completion: 2012-02
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-30
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative	conservative	This arm only has medical standard handling (healings performed by the nurse group)
Foam sclerotherapy	Foam sclerotherapy	This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Occidente de Kennedy; 🇨🇴 Bogota, Cundinamarca, Colombia