Chronic Venous Insufficiency and Balneotherapy

CEN Biotech

Status

Completed

Conditions

Venous Insufficiency (Chronic)(Peripheral)

Treatments

Procedure: SPA THERAPY

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT06054737

C1688

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.