Clinical trial NCT06054737: Chronic Venous Insufficiency and Balneotherapy
Official title: Effectiveness of the Spa Therapy Program of Royat in Chronic Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Venous Insufficiency (Chronic)(Peripheral)
Keywords: Spa therapy,
Balneotherapy
Chronic venous insufficiency
CVI
CVD
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
Collaborators: name: TOWN HALL OF ROYAT
First posted: 2023-09-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in CIVIQ-2 score at 6 months
timeFrame: Baseline (D1) and final (6 months)
Secondary outcomes:
measure: Changes from baseline in Quality of Life at 6 months
timeFrame: Baseline (D1) and final (6 months)
measure: Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months
timeFrame: Baseline (D1) and final (6 months)
measure: Frequency of adverse events throughout the study
timeFrame: From inclusion to the final visit at 6 months]
measure: Participants' satisfaction with the spa therapy program at the end of the program and at 6 months
timeFrame: 20 days and 6 months
measure: Medical-economic impact of the spa therapy program at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Royat
country: France
facility: Thermes de Royat
state: Auvergne
Study officials:
affiliation: Private Practitioner
name: Geoffroy COUCHET, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.