Venous Ulcer Treatment With Foam Versus Conservative Treatment

Venous Ulcer Clinical Trial

— VUTEF  

Official title:

Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594658
• Other study ID #: VUT-3F
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: September 30, 2012
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Hospital Occidente de Kennedy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• 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.
• conservative
This arm only has medical standard handling (healings performed by the nurse group)

Locations

Country	Name	City	State
Colombia	Hospital Occidente de Kennedy	Bogota	Cundinamarca

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Occidente de Kennedy	Universidad El Bosque, Bogotá

Country where clinical trial is conducted

Colombia, 

References & Publications (2)

Darvall KA, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Ultrasound-guided foam sclerotherapy for the treatment of chronic venous ulceration: a preliminary study. Eur J Vasc Endovasc Surg. 2009 Dec;38(6):764-9. doi: 10.1016/j.ejvs.2009.05.027. Epub 2009 Jul 18. — View Citation

Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg. 2010 Dec;40(6):790-5. doi: 10.1016/j.ejvs.2010.08.011. Epub 2010 Sep 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Ulcer Treatment with Foam Versus Conservative Treatment	Number of participants with healing of venous ulcer after six months from the intervention.	6 months	No

External Links

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