Chronic Venous Insufficiency and Balneotherapy
- Conditions
- Venous Insufficiency (Chronic)(Peripheral)
- Interventions
- Procedure: SPA THERAPY
- Registration Number
- NCT06054737
- Lead Sponsor
- CEN Biotech
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SPA THERAPY PROGRAM SPA THERAPY 3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency
- Primary Outcome Measures
Name Time Method Changes from baseline in CIVIQ-2 score at 6 months 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 Outcome Measures
Name Time Method Changes from baseline in Quality of Life at 6 months 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).
Frequency of adverse events throughout the study From inclusion to the final visit at 6 months] Adverse events are described using MedDRA and each event frequency is calculated.
Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months Baseline (D1) and final (6 months) Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).
Participants' satisfaction with the spa therapy program at the end of the program and at 6 months 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")
Medical-economic impact of the spa therapy program at 6 months 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)
Trial Locations
- Locations (1)
Thermes de Royat
🇫🇷Royat, Auvergne, France