Venous UlcerVUTEFNCT01594658
Venous Ulcer Treatment With Foam Versus Conservative Treatment
An observational study of Venous Ulcer, run by Hospital Occidente de Kennedy at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Foam sclerotherapy and conservative
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with C6 by CEAP Clasification
Who may be able to join
- 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
Who cannot join
- Severe hepatic, cardiac or pulmonary disease
- Deep venous thrombosis
- Active participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment
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.
Read the 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
- Conditions
- Venous Ulcer
- Being tested
- Foam sclerotherapy, conservative
- Keywords
- Ultrasound-guided foam sclerotherapy; chronic venous ulcers
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam sclerotherapyProcedure or surgery
Also called (Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016
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.
conservativeProcedure or surgery
Also called This arm only has medical standard handling
This arm only has medical standard handling (healings performed by the nurse group)
| Study group | Role | What they receive |
|---|---|---|
| Foam sclerotherapy | This arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management Receives: Procedure: Foam sclerotherapy | |
| Conservative | This arm only has medical standard handling (healings performed by the nurse group) Receives: Procedure: conservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Ulcer Treatment with Foam Versus Conservative Treatment
Number of participants with healing of venous ulcer after six months from the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Occidente de Kennedy
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad El Bosque, Bogotá
- Responsible party
- Principal investigator, ernesto nieves, Hospital Occidente de Kennedy
- Investigators
- Miguel A Ramirez, MD, Study director, Hospital Occidente de Kennedy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594658
- Sponsor's protocol ID
- VUT-3F
- Acronym
- VUTEF
- Status last verified
- Sep 2012
- First submitted
- 18 Jul 2011
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20875753Darvall 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.
PubMed 19616975
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Random Study for Handling Venous Ulcer With Conservative Treatment (Dressings Alone) and Foam Sclerotherapy Versus Conservative Treatment
- ClinicalTrials.gov ID
- NCT01594658
- Acronym / sponsor ID
- VUTEF / VUT-3F
- Conditions
- Venous Ulcer
- Keywords
- Ultrasound-guided foam sclerotherapy; chronic venous ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospital Occidente de KennedyUniversity, hospital or other
- Collaborators
- Universidad El Bosque, Bogotá
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foam sclerotherapy | – | Procedure: Foam sclerotherapyThis arm corresponds to ultrasound-guided foam sclerotherapy of superficial venous reflux plus conservative management |
| Conservative | – | Procedure: conservativeThis arm only has medical standard handling (healings performed by the nurse group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with C6 by CEAP Clasification
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Severe hepatic, cardiac or pulmonary disease
- Deep venous thrombosis
- Active participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foam sclerotherapyAlso: (Sklerol®, ICV Pharma, Bogota-Col),Reg INVIMA: 2002M-0001016Foam 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. | Procedure or surgery | Foam sclerotherapy |
| conservativeAlso: This arm only has medical standard handlingThis arm only has medical standard handling (healings performed by the nurse group) | Procedure or surgery | Conservative |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Background: PubMed 20875753Pang 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.
- Background: PubMed 19616975Darvall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel A Ramirez, MD study director
Hospital Occidente de Kennedy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Ulcer, run by Hospital Occidente de Kennedy at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Ulcer Treatment with Foam Versus Conservative Treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.