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Chronic Venous Insufficiency and Balneotherapy

NCT06054737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2025-08-06

No results posted yet for this study

Summary

The aim of this clinical trial is to assess the efficacy of the balneotherapy program (therapeutic orientation: Phlebology) in terms of chronic venous disease improvement and related quality of life, in patients presented with advanced chronic venous insufficiency (i.e., with C4-C5 of severity classification).

The multicenter randomized controlled trial (RCT) "Thermes \& Veines" that aimed at evaluating balneotherapy in patients with advanced chronic venous insufficiency is considered as the reference study. The French National Academy of Medicine encourages the re-use of data of published RCT when available. In this context, the current study is designed as a single-arm prospective study with indirect comparison using propension score. The Control group consists of the 197 patients which were allocated to the Control group of the "Thermes \& Veines".

All patients enrolled in the current study benefit of 18-days of spa treatment with Mineral Water of Royat, and examination with vascular practitioner at enrollment and 6 months after the beginning of spa treatment.

Conditions

  • Venous Insufficiency (Chronic)(Peripheral)

Interventions

PROCEDURE

SPA THERAPY

Balneotherapy program Four balneotherapy sessions per day, 6 days a week during 3 weeks The balneotherapy sessions included: * 10- minute walking session in a specially designed pool with tracks in semideep (80 cm) cool (30°C) water (training of muscle pump function under water compression); * 20-minute whirlpool bath session with automatic air or submarine bath if hypodermis (aimed at relaxation and mobilization of the superficial skin volume flow); followed by a 10-minute hydrojet bath (2 sessions) with customized underwater strong massaging jets (mobilization and softening of the sclerotic subcutaneous tissues); * Fresh thermal water compresses at 24°C. The cool temperature of the compresses also has an analgesic and decongestant effect. This treatment is carried out last and is followed by a rest for a total duration of 60 minutes

Sponsors & Collaborators

  • TOWN HALL OF ROYAT

    collaborator UNKNOWN

  • CEN Biotech

    lead INDUSTRY

Principal Investigators

  • Geoffroy COUCHET, PD · Private Practitioner

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2024-06-27
Completion
2025-01-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054737 on ClinicalTrials.gov