Chronic Venous Insufficiency and Balneotherapy

NCT06054737 | Completed DMC

• 1 other identifier: C1688
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency (Chronic)(Peripheral)

Keywords

Spa therapy,; Balneotherapy; Chronic venous insufficiency; CVI; CVD

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in CIVIQ-2 score at 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).

  Baseline (D1) and final (6 months)

Secondary Outcomes (5)

• Changes from baseline in Quality of Life at 6 months

  Baseline (D1) and final (6 months)

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

  Baseline (D1) and final (6 months)

• Frequency of adverse events throughout the study

  From inclusion to the final visit at 6 months]

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

  20 days and 6 months

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

  6 months

Study Arms (1)

SPA THERAPY PROGRAM

3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency

Procedure: SPA THERAPY

Interventions

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

Also known as: BALNEOTHERAPY THERAPEUTIC ORIENTATION PHLEBOLOGY

SPA THERAPY PROGRAM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients meeting the eligibility criteria and living, or with possible accomodation, at less than 30 minutes from Royat (Auvergne, France)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CEN Biotech: lead
• TOWN HALL OF ROYAT: collaborator

Study Sites (1)

Thermes de Royat

Royat, Auvergne, 63130, France

Location

Related Publications (1)

• Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.

  PMID: 24135621 BACKGROUND

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Geoffroy COUCHET, PD

  Private Practitioner

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 26, 2023
• Study Start: September 25, 2023
• Primary Completion: June 27, 2024
• Study Completion: January 13, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)