Varicose UlcerVUERTNCT03293836
Venous Ulcer: Endovenous Radiofrequency Treatment Trial
A study testing Radiofrequency ablation and Multilayer Compressive Bandage in people with Varicose Ulcer and Varicose Veins of Lower Limb, run by Juliana Puggina at 1 site in Brazil.
Trial summary
The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in patients with active venous ulcer. This is a controlled, randomized prospective clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Ulcer, Varicose Veins of Lower Limb, Saphenous Vein Injury
- What is being tested?
- Radiofrequency ablation and Multilayer Compressive Bandage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2015to 31 Aug 2018
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years old
- venous ulcer appeared at least 4 weeks, bellow knee
- ankle-brachial index more than 0.9
- saphenous veins insufficiency plus perforating veins reflux
- saphenous vein diameter between 5 mm and 12 mm
- absence of saphenous veins thrombophlebitis
Show all 9Show fewer
- absence of personal history of venous deep thrombosis
- absence of ultrasound evidence of actual or previous venous deep thrombosis
- absence of severe ankle anquilosis
Who cannot join
- Unable to provide informed consent
- Unable to receive surgical intervention due to severe clinical condition
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)
São Paulo, São Paulo, 05403-010
Juliana Puggina, MD, +5511988604601, juliana.puggina@usp.br
Debora Nolli, +5511999707101, vuert.trial@gmail.com
About this study
Official title: Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in patients with active venous ulcer. This is a controlled, randomized prospective clinical trial. People with venous ulcers and primary venous insufficiency in superficial and perforating venous system will be studied. Participants will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. Clinical aspects, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12 months after ulcer healing.
- Being tested
- Radiofrequency ablation, Multilayer Compressive Bandage
- Keywords
- Varicose ulcer, Venous ulcer, Radiofrequency ablation, Perforating veins insufficiency, Varicose veins treatment
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
Multilayer Compressive BandageProcedure or surgery
Individual receive multilayer compressive bandage once a week
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency treatment | Experimental | Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment Receives: Procedure: Radiofrequency ablation; Procedure: Multilayer Compressive Bandage |
| Multilayer Compressive Bandage only | Active comparator | Receive only compressive treatment Receives: Procedure: Multilayer Compressive Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Healing - 12 w
Ulcers was already healed after 12 weeks
Measured: 12 weeks
Ulcer Healing - 24 w
Ulcers was already healed after 24 weeks
Measured: 24 weeks
Secondary outcomes (6)
Ulcer Recurrence
Ulcer recurrence rate after 1 year of follow up
Measured: 1 year
Quality of life SF-36
Increasing in individual's quality of life using SF 36
Measured: at the begginning and up to 1 week after ulcer had healed
Quality of life EQ- 5D
Increasing in individual's quality of life using EQ-5D
Measured: at the begginning and up to 1 week after ulcer had healed
Quality of life VLU-Qol
Increasing in individual's quality of life using VLU-Qol
Measured: at the begginning and up to 1 week after ulcer had healed
Quality of life CCVLUQ
Increasing in individual's quality of life using VLU-Qol
Measured: at the begginning and up to 1 week after ulcer had healed
Health Economic Assessment
A cost-effectiveness analysis will be performed using the collected data of resources used in participants care along the study. Cost-utility (QALY) will be calculated using EQ-5d questionarie data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jan 2015
- Primary completion31 Oct 2017 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juliana Puggina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Juliana Puggina, University of Sao Paulo
- Investigators
- Igor R Sincos, PhD, Principal investigator, University of Sao PauloJuliana Puggina, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293836
- Sponsor's protocol ID
- Vuert trial
- Other IDs
- UTN
- Acronym
- VUERT
- Status last verified
- Sep 2017
- First submitted
- 20 Mar 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puggina J, Sincos IR, Campos W Jr, Porta RMP, Dos Santos JB, De Luccia N, Puech-Leao P, Collares FB, da Silva ES. A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial). Phlebology. 2021 Apr;36(3):194-202. doi: 10.1177/0268355520951697. Epub 2020 Sep 14.
PubMed 32928070
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03293836
- Acronym / sponsor ID
- VUERT / Vuert trial
- Keywords
- Varicose ulcer, Venous ulcer, Radiofrequency ablation, Perforating veins insufficiency, Varicose veins treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Juliana PugginaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 26 Sep 2017 (actual)
- 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 aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in patients with active venous ulcer. This is a controlled, randomized prospective clinical trial. People with venous ulcers and primary venous insufficiency in superficial and perforating venous system will be studied. Participants will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. Clinical aspects, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12 months after ulcer healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency treatment | Experimental | Procedure: Radiofrequency ablation, Procedure: Multilayer Compressive BandageRadiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment |
| Multilayer Compressive Bandage only | Active comparator | Procedure: Multilayer Compressive BandageReceive only compressive treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age between 18 and 80 years old
- venous ulcer appeared at least 4 weeks, bellow knee
- ankle-brachial index more than 0.9
- saphenous veins insufficiency plus perforating veins reflux
- saphenous vein diameter between 5 mm and 12 mm
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Unable to receive surgical intervention due to severe clinical condition
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 |
|---|---|---|
| Radiofrequency ablationRadiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic) | Procedure or surgery | Radiofrequency treatment |
| Multilayer Compressive BandageIndividual receive multilayer compressive bandage once a week | Procedure or surgery | Multilayer Compressive Bandage only, Radiofrequency treatment |
Primary outcome
Ulcer Healing - 12 w
Time frame: 12 weeks
Ulcers was already healed after 12 weeks
Ulcer Healing - 24 w
Time frame: 24 weeks
Ulcers was already healed after 24 weeks
6 secondary outcomes
Ulcer Recurrence
Time frame: 1 year
Quality of life SF-36
Time frame: at the begginning and up to 1 week after ulcer had healed
Quality of life EQ- 5D
Time frame: at the begginning and up to 1 week after ulcer had healed
Quality of life VLU-Qol
Time frame: at the begginning and up to 1 week after ulcer had healed
Quality of life CCVLUQ
Time frame: at the begginning and up to 1 week after ulcer had healed
Health Economic Assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Derived from this study: PubMed 32928070Puggina J, Sincos IR, Campos W Jr, Porta RMP, Dos Santos JB, De Luccia N, Puech-Leao P, Collares FB, da Silva ES. A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial). Phlebology. 2021 Apr;36(3):194-202. doi: 10.1177/0268355520951697. Epub 2020 Sep 14.
- Individual participant dataSharing planned: No
Related trials for Varicose Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
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.
Igor R Sincos, PhD principal investigator
University of Sao Paulo
Juliana Puggina, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation and Multilayer Compressive Bandage in people with Varicose Ulcer and Varicose Veins of Lower Limb, run by Juliana Puggina at 1 site in Brazil.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Puggina, MD (+5511988604601, juliana.puggina@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer Healing - 12 w (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03293836, which also lists 1 linked publication.
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 26 Sep 2017.