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Completed

NCT Number: NCT06054737

Chronic Venous Insufficiency and Balneotherapy

The aim of this clinical trial is to assess the efficacy of the balneotherapy program (therapeutic orientation: Phlebology) in terms of chronic venous disease improvement and related quality of life, in patients presented with advanced chronic venous insufficiency (i.e., with C4-C5 of severity classification).

The multicenter randomized controlled trial (RCT) "Thermes & Veines" that aimed at evaluating balneotherapy in patients with advanced chronic venous insufficiency is considered as the reference study. The French National Academy of Medicine encourages the re-use of data of published RCT when available. In this context, the current study is designed as a single-arm prospective study with indirect comparison using propension score. The Control group consists of the 197 patients which were allocated to the Control group of the "Thermes & Veines".

All patients enrolled in the current study benefit of 18-days of spa treatment with Mineral Water of Royat, and examination with vascular practitioner at enrollment and 6 months after the beginning of spa treatment.

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Key information

Conditions

Venous Insufficiency (Chronic)(Peripheral) Cardiovascular Diseases Vascular Diseases Venous Insufficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Thermes de Royat

Royat, Auvergne, 63130, France

About this study

Chronic Vascular Disease (CVD) related quality of life and symptoms, as well as skin trophic changes from baseline are assessed at 6 months. Variations from baseline are compared in Control and Spa treatment groups. The indirect comparison methodology is based on the reuse of individual data from a "control" group and adjustment after calculating the propensity score.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary or post-thrombotic CVD with confirmed diagnosis by by duplex ultrasound examination (last available exam);
  • With CVI classified as C4a, C4b, or C5)
  • Available for balneotherapy program within the 2 next months
  • With health insurance affiliation.

Exclusion criteria

  • Active venous thrombosis, recent or ongoing erysipelas, peripheral arterial pathology (ankle brachial index < 0.70).
  • Walking difficulty
  • Neurologic diseases of the lower limbs
  • Presenting or likely to present a contraindication to thermal treatments, with planned surgery;
  • Having already benefited from a thermal treatment whatever the indication during the last 6 months
  • Chronic infectious disease, cancer, heart, kidney or liver failure;
  • Pregnant, breastfeeding women or women planning a pregnancy within the year;
  • Persons deprived of their liberty or subject to psychiatric care or subject to a measure of legal protection or unable to express their consent;
  • Patient likely to not respect the protocol or not to be able to attend the visits, particularly given the study follow-up;
  • Living at more than 30 minutes from the thermal site or who cannot be accommodated less than 30 minutes from the thermal site;
  • Already included in a clinical trial or in the exclusion period of a clinical trial.

Treatment and study plan

SPA THERAPY

Procedure

Balneotherapy program Four balneotherapy sessions per day, 6 days a week during 3 weeks

The balneotherapy sessions included:

  • 10- minute walking session in a specially designed pool with tracks in semideep (80 cm) cool (30°C) water (training of muscle pump function under water compression);
  • 20-minute whirlpool bath session with automatic air or submarine bath if hypodermis (aimed at relaxation and mobilization of the superficial skin volume flow); followed by a 10-minute hydrojet bath (2 sessions) with customized underwater strong massaging jets (mobilization and softening of the sclerotic subcutaneous tissues);
  • Fresh thermal water compresses at 24°C. The cool temperature of the compresses also has an analgesic and decongestant effect. This treatment is carried out last and is followed by a rest for a total duration of 60 minutes

Other names: BALNEOTHERAPY THERAPEUTIC ORIENTATION PHLEBOLOGY

Primary outcomes

  1. Changes from baseline in CIVIQ-2 score at 6 months

    Time frame: Baseline (D1) and final (6 months)

    The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) is a disease-specific instrument to measure the impact of chronic venous insufficiency on patients' lives. CIVIQ-2 or CIVIQ-20 is a self-administered questionnaire that consists in 20 questions of the CIVIQ result in a global score. All questions have a 5-point response category, with higher scores reflecting more severe impairment. The CIVIQ-20 score ranges from 20 (minimal impact) to 100 (maximal impact).

Secondary outcomes

  1. Changes from baseline in Quality of Life at 6 months

    Time frame: Baseline (D1) and final (6 months)

    Quality of life is measured using the generic EUROQOL (EQ-5D-3L) questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state).

  2. Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months

    Time frame: Baseline (D1) and final (6 months)

    Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).

  3. Frequency of adverse events throughout the study

    Time frame: From inclusion to the final visit at 6 months]

    Adverse events are described using MedDRA and each event frequency is calculated.

  4. Participants' satisfaction with the spa therapy program at the end of the program and at 6 months

    Time frame: 20 days and 6 months

    Opinion of the patient is measured using a 5-point Likert scale ranging from 1 ("not at all satisfied") to 5 ("very satisfied")

  5. Medical-economic impact of the spa therapy program at 6 months

    Time frame: 6 months

    EQ-5D-3L score at 6 months and frequency of adverse events related to chronic venous insufficiency.

    scores ranges from -0.541 (higher impact of health on quality of life) to 0.982 (lower impact of health on quality of life)

Sponsors and collaborators

Lead sponsor

CEN Biotech

Industry

Collaborators

  • TOWN HALL OF ROYAT

Registry information

Official study title

Effectiveness of the Spa Therapy Program of Royat in Chronic Venous Insufficiency

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 26, 2023
Registry last updated
Aug 6, 2025

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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