Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)

Hospital Occidente de Kennedy

Status: Completed

Conditions: Venous Ulcer

Treatments: Procedure: conservative; Procedure: Foam sclerotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT01594658

VUT-3F

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

46 participants in 2 patient groups

Foam sclerotherapy

Description:

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

Treatment:

Procedure: Foam sclerotherapy

Conservative

Description:

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

Treatment:

Procedure: conservative