Chronic Venous Insufficiency and Balneotherapy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Venous Insufficiency (Chronic)(Peripheral)
• Intervention / Treatment: Procedure: SPA THERAPY

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 Type: Observational
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Royat, Auvergne, France, 63130
      • Thermes de Royat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in Quality of Life at 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).	Baseline (D1) and final (6 months)
Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months	Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).	Baseline (D1) and final (6 months)
Frequency of adverse events throughout the study	Adverse events are described using MedDRA and each event frequency is calculated.	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	Opinion of the patient is measured using a 5-point Likert scale ranging from 1 ("not at all satisfied") to 5 ("very satisfied")	20 days and 6 months
Medical-economic impact of the spa therapy program at 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)	6 months

Collaborators and Investigators

• Sponsor: CEN Biotech
• Collaborators: TOWN HALL OF ROYAT
• Investigators: Principal Investigator: Geoffroy COUCHET, PD, Private Practitioner

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: CVD; Balneotherapy; Chronic venous insufficiency; CVI; Spa therapy,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: C1688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No