Status:
COMPLETED
Chronic Venous Insufficiency and Balneotherapy
Lead Sponsor:
CEN Biotech
Collaborating Sponsors:
TOWN HALL OF ROYAT
Conditions:
Venous Insufficiency (Chronic)(Peripheral)
Eligibility:
All Genders
18-80 years
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, ...
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 13 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06054737
Start Date
September 25 2023
End Date
January 13 2025
Last Update
August 6 2025
Active Locations (1)
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1
Thermes de Royat
Royat, Auvergne, France, 63130