Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01594658 |
Recruitment Status :
Completed
First Posted : May 9, 2012
Last Update Posted : October 2, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment |
---|---|
Venous Ulcer | Procedure: Foam sclerotherapy Procedure: conservative |
Study Type : | Observational |
Actual Enrollment : | 46 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | September 2012 |
Group/Cohort | Intervention/treatment |
---|---|
Foam sclerotherapy
This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management
|
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 |
Conservative
This arm only has medical standard handling (healings performed by the nurse group)
|
Procedure: conservative
This arm only has medical standard handling (healings performed by the nurse group)
Other Name: This arm only has medical standard handling |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594658
Colombia | |
Hospital Occidente de Kennedy | |
Bogota, Cundinamarca, Colombia |
Study Director: | Miguel A Ramirez, MD | Hospital Occidente de Kennedy |
Publications:
Responsible Party: | ernesto nieves, medical doctor, Hospital Occidente de Kennedy |
ClinicalTrials.gov Identifier: | NCT01594658 |
Other Study ID Numbers: |
VUT-3F |
First Posted: | May 9, 2012 Key Record Dates |
Last Update Posted: | October 2, 2012 |
Last Verified: | September 2012 |
Ultrasound-guided foam sclerotherapy; chronic venous ulcers |
Varicose Ulcer Ulcer Pathologic Processes Varicose Veins Vascular Diseases |
Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |