Venous Insufficiency (Chronic)(Peripheral)NCT06054737
Chronic Venous Insufficiency and Balneotherapy
An observational study of Venous Insufficiency (Chronic)(Peripheral), run by CEN Biotech at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Insufficiency (Chronic)(Peripheral)
- What is being tested?
- SPA THERAPY
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2023to 13 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients meeting the eligibility criteria and living, or with possible accomodation, at less than 30 minutes from Royat (Auvergne, France)
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- SPA THERAPY
- Keywords
- Spa therapy,, Balneotherapy, Chronic venous insufficiency, CVI, CVD
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPA THERAPYProcedure or surgery
Also called BALNEOTHERAPY THERAPEUTIC ORIENTATION PHLEBOLOGY
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
| Study group | Role | What they receive |
|---|---|---|
| SPA THERAPY PROGRAM | 3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency Receives: Procedure: SPA THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (D1) and final (6 months)
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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")
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start25 Sep 2023
- Primary completion27 Jun 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Insufficiency (Chronic)(Peripheral)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TOWN HALL OF ROYAT
- Responsible party
- Sponsor
- Investigators
- Geoffroy COUCHET, PD, Principal investigator, Private Practitioner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054737
- Sponsor's protocol ID
- C1688
- Status last verified
- Aug 2025
- First submitted
- 20 Sep 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24135621
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Spa Therapy Program of Royat in Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT06054737
- Acronym / sponsor ID
- C1688
- Keywords
- Spa therapy,, Balneotherapy, Chronic venous insufficiency, CVI, CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- TOWN HALL OF ROYAT
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPA THERAPY PROGRAM | – | Procedure: SPA THERAPY3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting the eligibility criteria and living, or with possible accomodation, at less than 30 minutes from Royat (Auvergne, France)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPA THERAPYAlso: BALNEOTHERAPY THERAPEUTIC ORIENTATION PHLEBOLOGYBalneotherapy 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 | Procedure or surgery | SPA THERAPY PROGRAM |
Primary outcome
Changes from baseline in CIVIQ-2 score at 6 months
Time frame: Baseline (D1) and final (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).
5 secondary outcomes
Changes from baseline in Quality of Life at 6 months
Time frame: Baseline (D1) and final (6 months)
Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months
Time frame: Baseline (D1) and final (6 months)
Frequency of adverse events throughout the study
Time frame: 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
Time frame: 20 days and 6 months
Medical-economic impact of the spa therapy program at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 24135621Carpentier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffroy COUCHET, PD principal investigator
Private Practitioner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Insufficiency (Chronic)(Peripheral), run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in CIVIQ-2 score at 6 months (time frame: Baseline (D1) and final (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.