MedDataX Logo

Venous Ulcer Treatment With Foam Versus Conservative Treatment

NCT ID: NCT01594658

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Ulcer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ultrasound-guided foam sclerotherapy; chronic venous ulcers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Foam sclerotherapy

This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management

Foam sclerotherapy

Intervention Type PROCEDURE

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)

conservative

Intervention Type PROCEDURE

This arm only has medical standard handling (healings performed by the nurse group)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

conservative

This arm only has medical standard handling (healings performed by the nurse group)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

(Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016 This arm only has medical standard handling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad El Bosque, Bogotá

OTHER

Sponsor Role collaborator

Hospital Occidente de Kennedy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ernesto nieves

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Miguel A Ramirez, MD

Role: STUDY_DIRECTOR

Hospital Occidente de Kennedy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Occidente de Kennedy

Bogota, Cundinamarca, Colombia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Colombia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20875753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19616975 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VUT-3F

Identifier Type: -

Identifier Source: org_study_id