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Venous Ulcer Treatment With Foam Versus Conservative Treatment (VUTEF)
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Purpose
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 | Intervention |
|---|---|
| Venous Ulcer | Procedure: Foam sclerotherapy Procedure: conservative |
| Study Type: | Observational |
| Study Design: | 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 |
- 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.
| Enrollment: | 46 |
| Study Start Date: | July 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01594658
| Colombia | |
| Hospital Occidente de Kennedy | |
| Bogota, Cundinamarca, Colombia | |
| Study Director: | Miguel A Ramirez, MD | Hospital Occidente de Kennedy |
More Information
Additional Information:
Publications:
| Responsible Party: | ernesto nieves, medical doctor, Hospital Occidente de Kennedy |
| ClinicalTrials.gov Identifier: | NCT01594658 History of Changes |
| Other Study ID Numbers: |
VUT-3F |
| Study First Received: | July 18, 2011 |
| Last Updated: | September 30, 2012 |
Keywords provided by ernesto nieves, Hospital Occidente de Kennedy:
|
Ultrasound-guided foam sclerotherapy; chronic venous ulcers |
Additional relevant MeSH terms:
|
Ulcer Varicose Ulcer Pathologic Processes Varicose Veins Vascular Diseases |
Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |
ClinicalTrials.gov processed this record on July 21, 2017