Clinical trial NCT01594658: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Ulcer
Keywords: Ultrasound-guided foam sclerotherapy; chronic venous ulcers
Lead sponsor: Hospital Occidente de Kennedy
Sponsor class: OTHER
Collaborators: name: Universidad El Bosque, Bogotá
First posted: 2012-05-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with C6 by CEAP Clasification

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

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

Primary outcomes:
measure: Venous Ulcer Treatment with Foam Versus Conservative Treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Occidente de Kennedy
state: Cundinamarca
Study officials:
affiliation: Hospital Occidente de Kennedy
name: Miguel A Ramirez, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.