Clinical trial NCT03293836: Venous Ulcer: Endovenous Radiofrequency Treatment Trial
Official title: Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Ulcer
Varicose Veins of Lower Limb
Saphenous Vein Injury
Keywords: Varicose ulcer
Venous ulcer
Radiofrequency ablation
Perforating veins insufficiency
Varicose veins treatment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-09-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Ulcer Healing - 12 w
timeFrame: 12 weeks
measure: Ulcer Healing - 24 w
timeFrame: 24 weeks
Secondary outcomes:
measure: Ulcer Recurrence
timeFrame: 1 year
measure: Quality of life SF-36
timeFrame: at the begginning and up to 1 week after ulcer had healed
measure: Quality of life EQ- 5D
timeFrame: at the begginning and up to 1 week after ulcer had healed
measure: Quality of life VLU-Qol
timeFrame: at the begginning and up to 1 week after ulcer had healed
measure: Quality of life CCVLUQ
timeFrame: at the begginning and up to 1 week after ulcer had healed
measure: Health Economic Assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Igor R Sincos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Juliana Puggina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.