Back to resultsChronic Venous Insufficiency and Balneotherapy
Primary Purpose
Chronic Venous Insufficiency, Chronic Venous Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPA THERAPY
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Venous Insufficiency focused on measuring Spa therapy, balneotherapy, CVI, CVD
Eligibility Criteria
Inclusion Criteria: Primary or post-thrombotic CVD with confirmed diagnosis by by duplex ultrasound examination (last available exam); With CVI classified as C4a, C4b, or C5) Available for balneotherapy program within the 2 next months With health insurance affiliation. Exclusion Criteria: Active venous thrombosis, recent or ongoing erysipelas, peripheral arterial pathology (ankle brachial index < 0.70). Walking difficulty Neurologic diseases of the lower limbs Presenting or likely to present a contraindication to thermal treatments, with planned surgery; Having already benefited from a thermal treatment whatever the indication during the last 6 months Chronic infectious disease, cancer, heart, kidney or liver failure; Pregnant, breastfeeding women or women planning a pregnancy within the year; Persons deprived of their liberty or subject to psychiatric care or subject to a measure of legal protection or unable to express their consent; Patient likely to not respect the protocol or not to be able to attend the visits, particularly given the study follow-up; Living at more than 30 minutes from the thermal site or who cannot be accommodated less than 30 minutes from the thermal site; Already included in a clinical trial or in the exclusion period of a clinical trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL
SPA THERAPY PROGRAM
Arm Description
Standard of care for advanced chronic venous insufficiency
3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency
Outcomes
Primary Outcome Measures
Changes from baseline in CIVIQ-2 score at 6 months
The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) is a disease-specific instrument to measure the impact of chronic venous insufficiency on patients' lives. CIVIQ-2 or CIVIQ-20 is a self-administered questionnaire that consists in 20 questions of the CIVIQ result in a global score. All questions have a 5-point response category, with higher scores reflecting more severe impairment. The CIVIQ-20 score ranges from 20 (minimal impact) to 100 (maximal impact).
Secondary Outcome Measures
Changes from baseline in Quality of Life at 6 months
Quality of life is measured using the generic EUROQOL (EQ-5D-3L) questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state).
Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months
Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).
Frequency of adverse events throughout the study
Adverse events are described using MedDRA and each event frequency is calculated.
Participants' satisfaction with the spa therapy program at the end of the program and at 6 months
Opinion of the patient is measured using a 5-point Likert scale
Medical-economic impact of the spa therapy program at 6 months
EQ-5D-3L score at 6 months and frequency of adverse events related to chronic venous insufficiency
Full Information
NCT ID
NCT06054737
First Posted
September 20, 2023
Last Updated
September 20, 2023
Sponsor
CEN Biotech
Collaborators
TOWN HALL OF ROYAT
1. Study Identification
Unique Protocol Identification Number
NCT06054737
Brief Title
Chronic Venous Insufficiency and Balneotherapy
Official Title
Effectiveness of the Spa Therapy Program of Royat in Chronic Venous Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEN Biotech
Collaborators
TOWN HALL OF ROYAT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency, Chronic Venous Disease
Keywords
Spa therapy, balneotherapy, CVI, CVD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-arm, superiority study with indirect comparison using control group of a reference study, and stratification based on severity class C4-C5 (ratio 3:2)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Standard of care for advanced chronic venous insufficiency
Arm Title
SPA THERAPY PROGRAM
Arm Type
Experimental
Arm Description
3-week spa therapy program with Mineral Water of Royat in addition to standard of care for chronic venous insufficiency
Intervention Type
Procedure
Intervention Name(s)
SPA THERAPY
Other Intervention Name(s)
BALNEOTHERAPY THERAPEUTIC ORIENTATION PHLEBOLOGY
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes from baseline in CIVIQ-2 score at 6 months
Description
The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) is a disease-specific instrument to measure the impact of chronic venous insufficiency on patients' lives. CIVIQ-2 or CIVIQ-20 is a self-administered questionnaire that consists in 20 questions of the CIVIQ result in a global score. All questions have a 5-point response category, with higher scores reflecting more severe impairment. The CIVIQ-20 score ranges from 20 (minimal impact) to 100 (maximal impact).
Time Frame
Baseline (D1) and final (6 months)
Secondary Outcome Measure Information:
Title
Changes from baseline in Quality of Life at 6 months
Description
Quality of life is measured using the generic EUROQOL (EQ-5D-3L) questionnaire. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state).
Time Frame
Baseline (D1) and final (6 months)
Title
Changes from baseline in 0-100 VAS leg pain related to chronic venous insufficiency at 6 months
Description
Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).
Time Frame
Baseline (D1) and final (6 months)
Title
Frequency of adverse events throughout the study
Description
Adverse events are described using MedDRA and each event frequency is calculated.
Time Frame
From inclusion to the final visit at 6 months]
Title
Participants' satisfaction with the spa therapy program at the end of the program and at 6 months
Description
Opinion of the patient is measured using a 5-point Likert scale
Time Frame
20 days and 6 months
Title
Medical-economic impact of the spa therapy program at 6 months
Description
EQ-5D-3L score at 6 months and frequency of adverse events related to chronic venous insufficiency
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary or post-thrombotic CVD with confirmed diagnosis by by duplex ultrasound examination (last available exam);
With CVI classified as C4a, C4b, or C5)
Available for balneotherapy program within the 2 next months
With health insurance affiliation.
Exclusion Criteria:
Active venous thrombosis, recent or ongoing erysipelas, peripheral arterial pathology (ankle brachial index < 0.70).
Walking difficulty
Neurologic diseases of the lower limbs
Presenting or likely to present a contraindication to thermal treatments, with planned surgery;
Having already benefited from a thermal treatment whatever the indication during the last 6 months
Chronic infectious disease, cancer, heart, kidney or liver failure;
Pregnant, breastfeeding women or women planning a pregnancy within the year;
Persons deprived of their liberty or subject to psychiatric care or subject to a measure of legal protection or unable to express their consent;
Patient likely to not respect the protocol or not to be able to attend the visits, particularly given the study follow-up;
Living at more than 30 minutes from the thermal site or who cannot be accommodated less than 30 minutes from the thermal site;
Already included in a clinical trial or in the exclusion period of a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine JUHEL, Ph.D
Phone
+33380680511
Email
christine.juhel@groupecen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine FRY
Phone
+33380680513
Email
amandine.fry@groupecen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffroy COUCHET, PD
Organizational Affiliation
Private Practitioner
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24135621
Citation
Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.
Results Reference
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Chronic Venous Insufficiency and Balneotherapy
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