Chronic Venous Insufficiency and Balneotherapy

Completed

• Conditions: Venous Insufficiency (Chronic)(Peripheral)

• 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.

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study Start: 2023-09-25
• Study First Posted: 2023-09-26
• Primary Completion: 2024-06-27
• Study Completion: 2025-01-13
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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