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OpenTrials
Completed

NCT Number: NCT03703765

Volume Estimation of the Limb After VEnous Treatment

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Angers

Angers, 49100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lower limb volume estimation

Device

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.

Primary outcomes

  1. Volume of lower limbs

    Time frame: 12 months

    Change of volume of the lower limbs will be assessed with a volumetric 3D scanner

Secondary outcomes

  1. Change in symptoms and quality of life

    Time frame: 12 months

    Change in symptoms and quality of life of patients assessed with the CIVIQ questionnaire

  2. Change in symptoms and quality of life

    Time frame: 12 months

    Change in symptoms and quality of life of patients assessed with the SF36 questionnaire

  3. Change in symptoms and quality of life

    Time frame: 12 months

    Change in symptoms and quality of life of patients assessed with the Villalta score for patients treated for post thrombotic syndrome

  4. Change in symptoms and quality of life

    Time frame: 12 months

    Change in symptoms and quality of life of patients assessed with the CEAP classification for patients treated for superficial venous insufficiency

  5. Validity

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: VELVET

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2018
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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