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Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)

This study has been completed.
Sponsor:
Collaborator:
Universidad El Bosque, Bogotá
Information provided by (Responsible Party):
ernesto nieves, Hospital Occidente de Kennedy
ClinicalTrials.gov Identifier:
NCT01594658
First received: July 18, 2011
Last updated: September 30, 2012
Last verified: September 2012

July 18, 2011
September 30, 2012
July 2011
February 2012   (final data collection date for primary outcome measure)
Venous Ulcer Treatment with Foam Versus Conservative Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of participants with healing of venous ulcer after six months from the intervention.
Same as current
Complete list of historical versions of study NCT01594658 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Venous Ulcer Treatment With Foam Versus Conservative Treatment
Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment

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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with C6 by CEAP Clasification

Venous Ulcer
  • 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.
    Other Name: (Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016
  • Procedure: conservative
    This arm only has medical standard handling (healings performed by the nurse group)
    Other Name: This arm only has medical standard handling
  • Foam sclerotherapy
    This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management
    Intervention: Procedure: Foam sclerotherapy
  • Conservative
    This arm only has medical standard handling (healings performed by the nurse group)
    Intervention: Procedure: conservative

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
September 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01594658
VUT-3F
No
ernesto nieves, Hospital Occidente de Kennedy
Hospital Occidente de Kennedy
Universidad El Bosque, Bogotá
Study Director: Miguel A Ramirez, MD Hospital Occidente de Kennedy
Hospital Occidente de Kennedy
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP