Actively Recruiting
Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency
Led by Société d'Exploitation des Thermes d'Amnéville · Updated on 2026-03-02
84
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
S
Société d'Exploitation des Thermes d'Amnéville
Lead Sponsor
S
Slb Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Severe chronic venous insufficiency of the lower limbs (C4a,b,c - C5) confirmed by venous Doppler ultrasound
- Indicated for a thermal cure focused on phlebology
- Available for a 3-week consecutive thermal cure at Saint-Eloy Thermal Center and 6 months follow-up
- Able to attend scheduled visits and complete data collection
- Women of childbearing age using effective contraception
- Affiliated with a health insurance plan or beneficiary
- Provided written informed consent for participation
You will not qualify if you...
- Contraindication to thermal cure
- Participation in any thermal cure within the last 9 months
- Healed lower limb ulcer within the last 3 months
- No venous trophic disorders or only mild chronic venous insufficiency (class C3 or less) in both legs
- Open ulcer on lower limb (class C6)
- Planned interventional venous treatment within next 6 months
- Scheduled orthopedic surgery on lower limbs within next 6 months
- Unable to walk
- Known allergy to sulfur
- Significant medical conditions affecting safety or study participation
- Participating in another clinical trial or exclusion period not ended
- Vulnerable persons as defined by French Public Health Code
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Thermal Saint-Eloy
Amnéville, France, 57360
Actively Recruiting
Research Team
Y
Youna PERON
CONTACT
G
Guillaume DUMAS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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