VUERT: Venous Ulcer: Endovenous Radiofrequency Treatment Trial

• Sponsor: Juliana Puggina (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03293836
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 44
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Ulcer; Varicose Veins of Lower Limb; Saphenous Vein Injury	Procedure: Radiofrequency ablation; Procedure: Multilayer Compressive Bandage	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial
• Actual Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Oct 31, 2017
• Anticipated Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiofrequency treatment Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment	Procedure: Radiofrequency ablation; Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic); Procedure: Multilayer Compressive Bandage; Individual receive multilayer compressive bandage once a week
Active Comparator: Multilayer Compressive Bandage only Receive only compressive treatment	Procedure: Multilayer Compressive Bandage; Individual receive multilayer compressive bandage once a week

Outcome Measures

Primary Outcome Measures

1. Ulcer Healing - 12 w [12 weeks]

   Ulcers was already healed after 12 weeks

2. Ulcer Healing - 24 w [24 weeks]

   Ulcers was already healed after 24 weeks

Secondary Outcome Measures

1. Ulcer Recurrence [1 year]

   Ulcer recurrence rate after 1 year of follow up

2. Quality of life SF-36 [at the begginning and up to 1 week after ulcer had healed]

   Increasing in individual's quality of life using SF 36

3. Quality of life EQ- 5D [at the begginning and up to 1 week after ulcer had healed]

   Increasing in individual's quality of life using EQ-5D

4. Quality of life VLU-Qol [at the begginning and up to 1 week after ulcer had healed]

   Increasing in individual's quality of life using VLU-Qol

5. Quality of life CCVLUQ [at the begginning and up to 1 week after ulcer had healed]

   Increasing in individual's quality of life using VLU-Qol

6. Health Economic Assessment [1 year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)	Sao Paulo	São Paulo	Brazil	05403-010

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Igor R Sincos, PhD, University of São Paulo
• Principal Investigator: Juliana Puggina, MD, University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Juliana Puggina, MD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03293836
• Other Study ID Numbers: Vuert trial; UTN
• First Posted: Sep 26, 2017
• Last Update Posted: Sep 26, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Juliana Puggina, MD, University of Sao Paulo: Varicose ulcer; Venous ulcer; Radiofrequency ablation; Perforating veins insufficiency; Varicose veins treatment
• Additional relevant MeSH terms: Varicose Veins; Varicose Ulcer; Ulcer

Study Results

No Results Posted as of Sep 26, 2017