Venous Insufficiency of LegAMNEVILLE-PHLNCT07362719
Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency
A study testing Phlebology oriented thermal cure in people with Venous Insufficiency of Leg, run by Société d'Exploitation des Thermes d'Amnéville at 1 site in France.
Trial summary
Chronic venous insufficiency (CVI) is a common progressive vascular disease that affects nearly one-third of the French population. Despite considerable advances in the treatment of chronic venous insufficiency, this condition remains a burden for patients and national healthcare systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency of Leg
- What is being tested?
- Phlebology oriented thermal cure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female (≥ 18 years of age).
- Patients with severe chronic venous insufficiency of the lower limbs (C4a,b,c - C5 according to the CEAP (Clinical manifestations, Etiology, Anatomic distibution, Pathophysiology) classification (2020 revision) for at least one of the legs) confirmed by venous Doppler ultrasound of the lower limbs.
- Patients with an indication for a thermal cure exclusively focused on phlebology.
- Patients available to participate in a 3-week consecutive thermal cure at the Saint-Eloy Thermal Center, followed by 6 months of clinical follow-up, in accordance with the protocol schedule.
- Patients available to attend the visits scheduled in the protocol and able to complete the data collection documents.
- For women of childbearing age: patient using effective contraception.
- Patient affiliated with a health insurance plan or beneficiary (Art. L.1121-8-1, French Public Health Code).
- Patient who has given their informed consent in writing regarding their participation in the protocol.
Who cannot join
- Patients with a contraindication to thermal cure.
- Patients who have participated in thermal cure (regardless of type) within the last 9 months.
- Patients who have had an ulcer on their lower limbs that has healed within the last 3 months.
- Patients without venous trophic disorders of the lower limbs, and in particular patients with isolated class C3 chronic venous insufficiency or less in both lower limbs.
- Patients with an open ulcer on a lower limb (class C6).
- Patients for whom interventional venous treatment is due to begin within the next 6 months.
Show all 12Show fewer
- Patients scheduled to undergo orthopedic surgery on the lower limbs within the next 6 months.
- Patients who are unable to walk.
- Patients with a known allergy to sulfur.
- Patients with any medically significant findings or significant history that may impact safety, interpretation of results, and/or subject participation in the study at 6 months, in the investigator's opinion.
- Patients simultaneously participating in another clinical trial or who have participated in another clinical trial for which the exclusion period has not ended.
- Vulnerable persons (Art. L.1121-5 to 8, and L1122-1-2, French Public Health Code).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Thermal Saint-Eloy
Amnéville, 57360
Claudine INVERNIZZI, +33 3 87 70 99 43, contact_steloy@polethermal.com
Claudine INVERNIZZI
About this study
Chronic venous insufficiency (CVI) is a common progressive vascular disease that affects nearly one-third of the French population. Despite considerable advances in the treatment of chronic venous insufficiency, this condition remains a burden for patients and national healthcare systems.
Balneotherapy-which includes thermal cures-is part of the therapeutic arsenal used in the treatment of chronic venous insufficiency. It is a relatively effective alternative with a relatively low cost compared to drug or surgical treatments. Phlebology is a thermal treatment orientation recognized by the French social security system.
The Saint-Eloy Thermal Center is listed among the thermal stations approved by the French Ministry of Health. It currently uses thermal water from Amnéville-les-Thermes to treat rheumatological and respiratory conditions, and wants to expand its range of orientations by adding phlebology. The AMNEVILLE-PHL study therefore aims to evaluate the efficacy and safety of the Saint-Eloy thermal cure for phlebology in patients suffering from severe chronic venous insufficiency.
- Conditions
- Venous Insufficiency of Leg
- Being tested
- Phlebology oriented thermal cure
- Keywords
- Severe chronic venous insufficiency, Thermal cure, Phlebology, Balneology, Venous Insufficiency of Leg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phlebology oriented thermal cureOther
The phlebology oriented thermal cure takes place over a period of 3 consecutive weeks, with 6 days of cure per week (Monday to Saturday, i.e. 18 days). It includes 72 treatment sessions over the 18-day period and three medical consultations (including an initial consultation, a mid-course consultation, and a final consultation) organized by the resort's thermal doctors. The treatment program is established by the thermal doctor based on the patient's clinical profile.
| Study group | Role | What they receive |
|---|---|---|
| Interventional (with phlebology-oriented thermal cure) | Experimental | Participants suffering from severe chronic venous insufficiency receiving thermal treatment at the Saint-Eloy Thermal Center Receives: Other: Phlebology oriented thermal cure |
| Control (no thermal cure) | No intervention | Participants suffering from severe chronic venous insufficiency without thermal treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in relieving symptoms of severe chronic venous insufficiency
Measurement of the evolution in the modified Venous Clinical Severity Score (mVCSS ).
The Venous Clinical Severity Score (VCSS) is composed of 10 items evaluating 8 clinical signs (pain, varicose veins, edema, skin pigmentation, inflammation, induration, ulcer, use of compression device). Each clinical sign is assessed on a scale of 0 to 3 (Absent (0), Mild (1), Moderate (2), Severe (3)) with a total VCSS score ranging from 0 to 30. The mVCSS excludes the item about the use of compression device because the thermal cure includes raising patient awareness about the importance of wearing compression devices. Thus, the modified VCSS score consists of 9 items with a total score ranging from 0 to 27. The lower the score, the fewer symptoms the patient has. The score is rated for both legs, but only the most severe leg based on the score at Baseline will be retained for the Primary Outcome Measure.
The mVCSS is rated by an independant evaluator, and will be compared between both arms.
Measured: At baseline, at 3 months
Secondary outcomes (12)
Efficacy in relieving symptoms of severe chronic venous insufficiency
Measurement of the evolution in the mVCSS (modified Venous Clinical Severity Score), as described in the primary outcome measure.
The modified VCSS score consists of 9 items with a total score ranging from 0 to 27. It is rated for both legs.
Measured: At baseline, at 3 months, at 6 months
Efficacy in relieving symptoms of severe chronic venous insufficiency
Measurement of the evolution in the complete VCSS (Venous Clinical Severity Score).
The complete VCSS is composed of 10 items evaluating 8 clinical signs (pain, varicose veins, edema, skin pigmentation, inflammation, induration, ulcer, use of compression device). Each clinical sign is assessed on a scale of 0 to 3 (Absent, Mild, Moderate, Severe) with a total VCSS score ranging from 0 to 30.
Measured: At baseline, at 3 months, at 6 months
Pathology-related quality of life assessment
Self assessment of quality of life using the ChronIc Venous Insuficiency quality of life Questionnaire composed of 20 items (CIVIQ-20).
The CIVIQ-20 is especially developped to assess the impact of chronic venous insufficiency on the patient's quality of life. A score will be calculated based on the questionnaire, from 20 to 100. The lower the score, the better the patient's quality of life.
Measured: At baseline, at 3 months, at 6 months
Quality of life assessment
Self assessment of quality of life using the 5-dimension 5-level EuroQol (EQ-5D-5L) questionnaire, to assess the patient's general quality of life. The questionnaire consists of five questions (mobility, personal autonomy, daily activities, pain/discomfort, anxiety/depression) and a visual analog scale (VAS).
For each patient, a health status (ranging from 11111 to 55555) will be obtained.
Measured: At baseline, at 3 months, at 6 months
Impact on patient discomfort
Self assessment of the patient's discomfort intensity due to the chronic venous insufficiency, using a Visual Analog Scale (VAS) [10 cm line].
A 10 cm line represents the intensity of the patient's discomfort. The patient places their discomfort on this line. 0 cm corresponds to a total absence of discomfort. 10 cm represents the worst discomfort the patient can imagine. The closer the patient places themselves to 10 cm, the worse their discomfort is.
Measured: At baseline, at 3 months, at 6 months
Impact on skin pigmentation
Chromametric measurement on the calf skin using a chromameter.
Measured: At baseline, at 3 months, at 6 months
Safety of Thermal Cure
Adverse events and serious adverse events occurence. Skin, mobility, and vascular events are recorded.
Measured: Through study completion, an average of 6 months
Impact of the thermal cure focused on the the patient's clinical evolution assessed by the investigator
Assessment of the clinical evolution by an independant evaluator using a 3-point Likert scale: better, neither better nor worse, worse.
Measured: At 3 months, at 6 months
Impact of the thermal cure focused on the the patient's clinical evolution self-assessed by the patient
Self-assessment by the patient of his clinical evolution, using a 3-point Likert scale: better, neither better nor worse, worse.
Measured: At 3 months, at 6 months
Compliance for wearing compression devices
Assessment of the compliance for wearing compression devices using the "Compression therapy" item of the VCSS (Venous Clinical Severity Score), that goes from 0 to 3.
Measured: At baseline, at 3 months, at 6 months
Patient satisfaction with the Saint-Eloy phlebology-oriented thermal cure
Satisfaction questionnaire with 23 items for the patients of the interventionnal arm. The passation of the questionnaire is done at the end of the thermal cure.
18 items use a numeric scale from 1 to 5 and 1 item use a numeric scale from 0 to 10. The minimal score is 18 and the maximal score is 100. The higher the score, the greater the patient satisfaction.
2 items are binary closed questions (Yes/No). Positive responses correlate with patient satisfaction.
2 items are optional open questions for positive or negative comments.
Measured: Between 3 weeks and 2 months
Medico-economic impact
Measurement of health care consumption and absenteeism at work through closed-ended questions.
Measured: At baseline, at 3 months, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start27 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Insufficiency of LegStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société d'Exploitation des Thermes d'Amnéville
- Sponsor type
- University, hospital or other
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Claudine INVERNIZZI, Principal investigatorYouna PERON, Study director, Slb Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362719
- Sponsor's protocol ID
- AMNEVILLE-PHL
- Acronym
- AMNEVILLE-PHL
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT07362719
- Acronym / sponsor ID
- AMNEVILLE-PHL / AMNEVILLE-PHL
- Conditions
- Venous Insufficiency of Leg
- Keywords
- Severe chronic venous insufficiency, Thermal cure, Phlebology, Balneology, Venous Insufficiency of Leg
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Société d'Exploitation des Thermes d'AmnévilleUniversity, hospital or other
- Collaborators
- Slb Pharma
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
Chronic venous insufficiency (CVI) is a common progressive vascular disease that affects nearly one-third of the French population. Despite considerable advances in the treatment of chronic venous insufficiency, this condition remains a burden for patients and national healthcare systems.
Balneotherapy-which includes thermal cures-is part of the therapeutic arsenal used in the treatment of chronic venous insufficiency. It is a relatively effective alternative with a relatively low cost compared to drug or surgical treatments. Phlebology is a thermal treatment orientation recognized by the French social security system.
The Saint-Eloy Thermal Center is listed among the thermal stations approved by the French Ministry of Health. It currently uses thermal water from Amnéville-les-Thermes to treat rheumatological and respiratory conditions, and wants to expand its range of orientations by adding phlebology. The AMNEVILLE-PHL study therefore aims to evaluate the efficacy and safety of the Saint-Eloy thermal cure for phlebology in patients suffering from severe chronic venous insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional (with phlebology-oriented thermal cure) | Experimental | Other: Phlebology oriented thermal cureParticipants suffering from severe chronic venous insufficiency receiving thermal treatment at the Saint-Eloy Thermal Center |
| Control (no thermal cure) | No intervention | –Participants suffering from severe chronic venous insufficiency without thermal treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult male or female (≥ 18 years of age).
- Patients with severe chronic venous insufficiency of the lower limbs (C4a,b,c - C5 according to the CEAP (Clinical manifestations, Etiology, Anatomic distibution, Pathophysiology) classification (2020 revision) for at least one of the legs) confirmed by venous Doppler ultrasound of the lower limbs.
- Patients with an indication for a thermal cure exclusively focused on phlebology.
- Patients available to participate in a 3-week consecutive thermal cure at the Saint-Eloy Thermal Center, followed by 6 months of clinical follow-up, in accordance with the protocol schedule.
- Patients available to attend the visits scheduled in the protocol and able to complete the data collection documents.
Key exclusion criteria (12 listed)
- Patients with a contraindication to thermal cure.
- Patients who have participated in thermal cure (regardless of type) within the last 9 months.
- Patients who have had an ulcer on their lower limbs that has healed within the last 3 months.
- Patients without venous trophic disorders of the lower limbs, and in particular patients with isolated class C3 chronic venous insufficiency or less in both lower limbs.
- Patients with an open ulcer on a lower limb (class C6).
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 |
|---|---|---|
| Phlebology oriented thermal cureThe phlebology oriented thermal cure takes place over a period of 3 consecutive weeks, with 6 days of cure per week (Monday to Saturday, i.e. 18 days). It includes 72 treatment sessions over the 18-day period and three medical consultations (including an initial consultation, a mid-course consultation, and a final consultation) organized by the resort's thermal doctors. The treatment program is established by the thermal doctor based on the patient's clinical profile. | Other | Interventional (with phlebology-oriented thermal cure) |
Primary outcome
Efficacy in relieving symptoms of severe chronic venous insufficiency
Time frame: At baseline, at 3 months
Measurement of the evolution in the modified Venous Clinical Severity Score (mVCSS ). The Venous Clinical Severity Score (VCSS) is composed of 10 items evaluating 8 clinical signs (pain, varicose veins, edema, skin pigmentation, inflammation, induration, ulcer, use of compression device). Each clinical sign is assessed on a scale of 0 to 3 (Absent (0), Mild (1), Moderate (2), Severe (3)) with a total VCSS score ranging from 0 to 30. The mVCSS excludes the item about the use of compression device because the thermal cure includes raising patient awareness about the importance of wearing compression devices. Thus, the modified VCSS score consists of 9 items with a total score ranging from 0 to 27. The lower the score, the fewer symptoms the patient has. The score is rated for both legs, but only the most severe leg based on the score at Baseline will be retained for the Primary Outcome Measure. The mVCSS is rated by an independant evaluator, and will be compared between both arms.
12 secondary outcomes
Efficacy in relieving symptoms of severe chronic venous insufficiency
Time frame: At baseline, at 3 months, at 6 months
Efficacy in relieving symptoms of severe chronic venous insufficiency
Time frame: At baseline, at 3 months, at 6 months
Pathology-related quality of life assessment
Time frame: At baseline, at 3 months, at 6 months
Quality of life assessment
Time frame: At baseline, at 3 months, at 6 months
Impact on patient discomfort
Time frame: At baseline, at 3 months, at 6 months
Impact on skin pigmentation
Time frame: At baseline, at 3 months, at 6 months
Safety of Thermal Cure
Time frame: Through study completion, an average of 6 months
Impact of the thermal cure focused on the the patient's clinical evolution assessed by the investigator
Time frame: At 3 months, at 6 months
Impact of the thermal cure focused on the the patient's clinical evolution self-assessed by the patient
Time frame: At 3 months, at 6 months
Compliance for wearing compression devices
Time frame: At baseline, at 3 months, at 6 months
Patient satisfaction with the Saint-Eloy phlebology-oriented thermal cure
Time frame: Between 3 weeks and 2 months
Medico-economic impact
Time frame: At baseline, at 3 months, at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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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.
Claudine INVERNIZZI principal investigator
Youna PERON study director
Slb Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phlebology oriented thermal cure in people with Venous Insufficiency of Leg, run by Société d'Exploitation des Thermes d'Amnéville 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ophélie FLAGEUL (+33 2 99 12 19 62, o.flageul@slbpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in relieving symptoms of severe chronic venous insufficiency (time frame: At baseline, at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.