Venous Insufficiency Clinical Trials

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Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Thermal Saint-Eloy
RECRUITING
Amnéville
Contact Information
Primary
Youna PERON
y.peron@slbpharma.com
+33 2 99 12 19 62
Backup
Guillaume DUMAS
gdumas@polethermal.com
+33 3 87 71 83 52
Time Frame
Start Date: 2026-02-27
Estimated Completion Date: 2027-05
Participants
Target number of participants: 84
Treatments
Experimental: Interventional (with phlebology-oriented thermal cure)
Participants suffering from severe chronic venous insufficiency receiving thermal treatment at the Saint-Eloy Thermal Center
No_intervention: Control (no thermal cure)
Participants suffering from severe chronic venous insufficiency without thermal treatment.
Related Therapeutic Areas
Sponsors
Leads: Société d'Exploitation des Thermes d'Amnéville
Collaborators: Slb Pharma

This content was sourced from clinicaltrials.gov