Actively Recruiting
Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in Treating Severe Chronic Venous Insufficiency Symptoms
Led by Société d'Exploitation des Thermes d'Amnéville · Updated on 2026-03-02
84
Participants Needed
1
Research Sites
12 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 and progressive vascular disease affecting many people, causing a burden for patients and healthcare systems. Researchers are studying the effectiveness and safety of a phlebology-oriented thermal cure at the Saint-Eloy Thermal Center in France, which uses thermal water treatments to help manage symptoms of severe chronic venous insufficiency. This study aims to assess this thermal treatment as an alternative to drug or surgical options. The study compares two groups of participants with severe chronic venous insufficiency: one group receives the thermal cure at the Saint-Eloy Thermal Center, while the other does not receive thermal treatment. The thermal cure lasts for 3 consecutive weeks, with treatments six days per week, totaling 72 sessions, along with three medical consultations. The treatment plan is personalized by thermal doctors based on each patient's clinical profile. Participants will be involved in the 3-week treatment phase followed by 6 months of clinical follow-up to monitor symptom relief and quality of life. Researchers will assess treatment effectiveness at baseline, 3 months, and 6 months, including symptoms, skin changes, patient discomfort, compliance with compression devices, and patient satisfaction. Safety is monitored throughout the study. The total participation includes treatment and follow-up visits over several months.
CONDITIONS
Brief 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
- Diagnosed with severe chronic venous insufficiency of the lower limbs (C4a,b,c - C5) confirmed by venous Doppler ultrasound
- Indicated for a thermal cure focused only on phlebology
- Able to participate in a 3-week consecutive thermal cure and 6 months of follow-up
- Able to attend all scheduled visits and complete data collection
- Women of childbearing age must use effective contraception
- Affiliated with a health insurance plan
- Provided written informed consent
You will not qualify if you...
- Contraindication to thermal cure
- Received 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 a lower limb (class C6)
- Scheduled for interventional venous treatment within 6 months
- Scheduled for orthopedic surgery on lower limbs within 6 months
- Unable to walk
- Known allergy to sulfur
- Medically significant conditions that affect safety or study results
- Currently or recently participating in another clinical trial with an active exclusion period
- Vulnerable persons as defined by French Public Health Code
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive the phlebology-oriented thermal cure over 3 consecutive weeks with treatments and medical consultations organized by thermal doctors.
6 days per week for 3 weeks, including 72 treatment sessions and 3 medical consultations
Duration - Up to 6 months
Participants are followed up to assess symptom relief, quality of life, and safety for up to 6 months after treatment.
Visits at 3 months and 6 months
Trial Site Locations
Total: 1 location
1
Centre Thermal Saint-Eloy
Amnéville, France, 57360
Actively Recruiting
Research Team
Y
Youna PERON
G
Guillaume DUMAS
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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