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Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)

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ClinicalTrials.gov Identifier: NCT01594658
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : October 2, 2012
Sponsor:
Collaborator:
Universidad El Bosque, Bogotá
Information provided by (Responsible Party):
ernesto nieves, Hospital Occidente de Kennedy

Tracking Information
First Submitted Date July 18, 2011
First Posted Date May 9, 2012
Last Update Posted Date October 2, 2012
Study Start Date July 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2012)
Venous Ulcer Treatment with Foam Versus Conservative Treatment [ Time Frame: 6 months ]
Number of participants with healing of venous ulcer after six months from the intervention.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Venous Ulcer Treatment With Foam Versus Conservative Treatment
Official Title Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with C6 by CEAP Clasification
Condition Venous Ulcer
Intervention
  • 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
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 30, 2012)
46
Original Estimated Enrollment
 (submitted: May 7, 2012)
40
Actual Study Completion Date September 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Colombia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01594658
Other Study ID Numbers VUT-3F
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ernesto nieves, Hospital Occidente de Kennedy
Study Sponsor Hospital Occidente de Kennedy
Collaborators Universidad El Bosque, Bogotá
Investigators
Study Director: Miguel A Ramirez, MD Hospital Occidente de Kennedy
PRS Account Hospital Occidente de Kennedy
Verification Date September 2012