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Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07362719

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 patients 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

Y

Youna PERON

G

Guillaume DUMAS

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