Volume Estimation of the Limb After VEnous Treatment (VELVET)

Volume Estimation of Lower Limbs Before and After Endovascular Venous Intervention or Conventional Surgery in Venous Disease

Chronic venous disease encompasses a broad spectrum of clinical presentations and is considered the most common vascular disease. Its causes are diverse, including primary defects of the wall or valves, chronic venous insufficiency, or lesions secondary to thrombosis, a post-thrombotic venous disease, affecting the superficial or deep venous network or both. The major symptom of venous disease is the enlargement of the lower limbs, which can result in edema. The evaluation of the volume of the lower limbs is very important in the diagnosis and follow-up of the venous pathology. There is a great variability of clinical pictures making it difficult to choose the therapeutic gesture. Endovascular venous interventions and conventional venous surgery are major advances in the treatment of venous disease. The variation of lower limb volume in pre and post procedure is a determining factor; thus orienting clinicians for post interventional therapeutic monitoring. Indeed the management of venous disease is multidisciplinary, it involves the cooperation of several specialists as part of its monitoring and its therapeutic management. Our collaborative group includes the Adult and Child Vascular Investigations Department, the Vascular Clinic, the Cardiovascular and Thoracic Surgery Department, and the Interventional Radiology Department. The evaluation of the variation of the volumes of the lower limbs is a capital data for the various specialists for the care in pre and post procedure. A volumetric 3D scanner system guarantees a reliable measurement ensuring optimal evolution and therapeutic follow-up.

Study Overview

• Status: Completed
• Conditions: Venous Disease
• Intervention / Treatment: Device: lower limb volume estimation

Detailed Description

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept.

In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, the evaluation of the variation of the volumes of the lower limbs with the volumetric 3D scanner will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • UH Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• subjects referred for investigation of a preoperative venous assessment
• affiliation to the French National healthcare system
• french speaking patients

Exclusion Criteria:

• pregnancy
• inability to understand the study goal
• patients protected by decision of law

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower limb volume estimation; Patients referred for a preoperative venous assessment as part of an indication for interventional management, whether by conventional or endovascular surgery, of a chronic venous pathology. Intervention is measurement of lower limb volume with scanner 3D system before and after surgery or vascular intervention.	Device: lower limb volume estimation; The 3D scanner system is a three-dimensional measurement system. It allows to evaluate the volume of the lower limbs in order to quantify the evolution of the edema of the lower limbs in the venous pathology in pre and post therapeutic technique. It is a non-invasive, easily accepted, non-invasive, non-invasive technique that minimizes discomfort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of lower limbs	Change of volume of the lower limbs will be assessed with a volumetric 3D scanner	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in symptoms and quality of life	Change in symptoms and quality of life of patients assessed with the CIVIQ questionnaire	12 months
Change in symptoms and quality of life	Change in symptoms and quality of life of patients assessed with the SF36 questionnaire	12 months
Change in symptoms and quality of life	Change in symptoms and quality of life of patients assessed with the Villalta score for patients treated for post thrombotic syndrome	12 months
Change in symptoms and quality of life	Change in symptoms and quality of life of patients assessed with the CEAP classification for patients treated for superficial venous insufficiency	12 months
Validity	To validate the measurement of the volume of the lower limbs by a 3D scanner system compared to measurement by a tape measure (gold standard) in venous disease.	1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: HENNI MD SAMIR, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: imaging; lower limb; veins; Volume
• Other Study ID Numbers: 2017-A02698-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No