CompletedNot Applicable

Chronic Venous Insufficiency and Balneotherapy

France64 participantsStarted 2023-09-25

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes from baseline in CIVIQ-2 score at 6 months

Timeframe: Baseline (D1) and final (6 months)

Trial details

NCT IDNCT06054737

SponsorCEN Biotech

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-06-27

View on ClinicalTrials.gov More Venous Insufficiency (Chronic)(Peripheral) trials