Venous Ulcer: Endovenous Radiofrequency Treatment Trial

NCT03293836 | Unknown DMC

• 2 other identifiers: Vuert trialUTN
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Varicose Ulcer; Varicose Veins of Lower Limb; Saphenous Vein Injury

Keywords

Varicose ulcer; Venous ulcer; Radiofrequency ablation; Perforating veins insufficiency; Varicose veins treatment

Outcome Measures

Primary Outcomes (2)

• Ulcer Healing - 12 w

  Ulcers was already healed after 12 weeks

  12 weeks

• Ulcer Healing - 24 w

  Ulcers was already healed after 24 weeks

  24 weeks

Secondary Outcomes (6)

• Ulcer Recurrence

  1 year

• Quality of life SF-36

  at the begginning and up to 1 week after ulcer had healed

• Quality of life EQ- 5D

  at the begginning and up to 1 week after ulcer had healed

• Quality of life VLU-Qol

  at the begginning and up to 1 week after ulcer had healed

• Quality of life CCVLUQ

  at the begginning and up to 1 week after ulcer had healed

Study Arms (2)

Radiofrequency treatment

EXPERIMENTAL

Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment

Procedure: Radiofrequency ablation; Procedure: Multilayer Compressive Bandage

Multilayer Compressive Bandage only

ACTIVE COMPARATOR

Receive only compressive treatment

Procedure: Multilayer Compressive Bandage

Interventions

Radiofrequency ablation PROCEDURE

Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)

Radiofrequency treatment

Multilayer Compressive Bandage PROCEDURE

Individual receive multilayer compressive bandage once a week

Multilayer Compressive Bandage only; Radiofrequency treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• absence of personal history of venous deep thrombosis
• absence of ultrasound evidence of actual or previous venous deep thrombosis
• absence of severe ankle anquilosis

You may not qualify if:

• Unable to provide informed consent
• Unable to receive surgical intervention due to severe clinical condition

Sponsors & Collaborators

• Juliana Puggina: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 32928070 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Igor R Sincos, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Juliana Puggina, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Puggina, MD

CONTACT

+5511988604601; juliana.puggina@usp.br

Igor R Sincos, PhD

CONTACT

+5511984477382; igorsincos@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: September 26, 2017
• Study Start: January 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: August 31, 2018
• Last Updated: September 26, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)