Volume Estimation of the Limb After VEnous Treatment

Venous Disease Clinical Trial

— VELVET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703765
• Other study ID #: 2017-A02698-45
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2024
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Venous Disease

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.

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of lower limbs	Change of volume of the lower limbs will be assessed with a volumetric 3D scanner	12 months
Secondary	Change in symptoms and quality of life	Change in symptoms and quality of life of patients assessed with the CIVIQ questionnaire	12 months
Secondary	Change in symptoms and quality of life	Change in symptoms and quality of life of patients assessed with the SF36 questionnaire	12 months
Secondary	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
Secondary	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
Secondary	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