NCT06054737

Chronic Venous Insufficiency and Balneotherapy

Effectiveness of the Spa Therapy Program of Royat in Chronic Venous Insufficiency

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: CEN Biotech · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chronic Vascular Disease (CVD) related quality of life and symptoms, as well as skin trophic changes from baseline are assessed at 6 months. Variations from baseline are compared in Control and Spa treatment groups. The indirect comparison methodology is based on the reuse of individual data from a "control" group and adjustment after calculating the propensity score.

Conditions

• Venous Insufficiency (Chronic)(Peripheral)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-06-27
• Completion: 2025-01-13
• First posted: 2023-09-26
• Last updated: 2025-08-06

Locations

1 site across 1 country: France