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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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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 AmnƩville-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional (with phlebology-oriented thermal cure) | Experimental | Participants suffering from severe chronic venous insufficiency receiving thermal treatment at the Saint-Eloy Thermal Center |
|
| Control (no thermal cure) | No Intervention | Participants suffering from severe chronic venous insufficiency without thermal treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phlebology oriented thermal cure | Other | The phlebology oriented thermal cure takes place over a period of 3 consecutive weeks, with 6 days of cure per week (Monday to Saturday, i.e. 18 days). It includes 72 treatment sessions over the 18-day period and three medical consultations (including an initial consultation, a mid-course consultation, and a final consultation) organized by the resort's thermal doctors. The treatment program is established by the thermal doctor based on the patient's clinical profile. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in relieving symptoms of severe chronic venous insufficiency | Measurement of the evolution in the modified Venous Clinical Severity Score (mVCSS ). The Venous Clinical Severity Score (VCSS) is composed of 10 items evaluating 8 clinical signs (pain, varicose veins, edema, skin pigmentation, inflammation, induration, ulcer, use of compression device). Each clinical sign is assessed on a scale of 0 to 3 (Absent (0), Mild (1), Moderate (2), Severe (3)) with a total VCSS score ranging from 0 to 30. The mVCSS excludes the item about the use of compression device because the thermal cure includes raising patient awareness about the importance of wearing compression devices. Thus, the modified VCSS score consists of 9 items with a total score ranging from 0 to 27. The lower the score, the fewer symptoms the patient has. The score is rated for both legs, but only the most severe leg based on the score at Baseline will be retained for the Primary Outcome Measure. The mVCSS is rated by an independant evaluator, and will be compared between both arms. | At baseline, at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in relieving symptoms of severe chronic venous insufficiency | Measurement of the evolution in the mVCSS (modified Venous Clinical Severity Score), as described in the primary outcome measure. The modified VCSS score consists of 9 items with a total score ranging from 0 to 27. It is rated for both legs. | At baseline, at 3 months, at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youna PERON | Contact | +33 2 99 12 19 62 | y.peron@slbpharma.com | |
| Guillaume DUMAS | Contact | +33 3 87 71 83 52 | gdumas@polethermal.com |
| Name | Affiliation | Role |
|---|---|---|
| Claudine INVERNIZZI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Thermal Saint-Eloy | Recruiting | AmnƩville | 57360 | France |
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| Efficacy in relieving symptoms of severe chronic venous insufficiency | Measurement of the evolution in the complete VCSS (Venous Clinical Severity Score). The complete VCSS is composed of 10 items evaluating 8 clinical signs (pain, varicose veins, edema, skin pigmentation, inflammation, induration, ulcer, use of compression device). Each clinical sign is assessed on a scale of 0 to 3 (Absent, Mild, Moderate, Severe) with a total VCSS score ranging from 0 to 30. | At baseline, at 3 months, at 6 months |
| Pathology-related quality of life assessment | Self assessment of quality of life using the ChronIc Venous Insuficiency quality of life Questionnaire composed of 20 items (CIVIQ-20). The CIVIQ-20 is especially developped to assess the impact of chronic venous insufficiency on the patient's quality of life. A score will be calculated based on the questionnaire, from 20 to 100. The lower the score, the better the patient's quality of life. | At baseline, at 3 months, at 6 months |
| Quality of life assessment | Self assessment of quality of life using the 5-dimension 5-level EuroQol (EQ-5D-5L) questionnaire, to assess the patient's general quality of life. The questionnaire consists of five questions (mobility, personal autonomy, daily activities, pain/discomfort, anxiety/depression) and a visual analog scale (VAS). For each patient, a health status (ranging from 11111 to 55555) will be obtained. | At baseline, at 3 months, at 6 months |
| Impact on patient discomfort | Self assessment of the patient's discomfort intensity due to the chronic venous insufficiency, using a Visual Analog Scale (VAS) [10 cm line]. A 10 cm line represents the intensity of the patient's discomfort. The patient places their discomfort on this line. 0 cm corresponds to a total absence of discomfort. 10 cm represents the worst discomfort the patient can imagine. The closer the patient places themselves to 10 cm, the worse their discomfort is. | At baseline, at 3 months, at 6 months |
| Impact on skin pigmentation | Chromametric measurement on the calf skin using a chromameter. | At baseline, at 3 months, at 6 months |
| Safety of Thermal Cure | Adverse events and serious adverse events occurence. Skin, mobility, and vascular events are recorded. | Through study completion, an average of 6 months |
| Impact of the thermal cure focused on the the patient's clinical evolution assessed by the investigator | Assessment of the clinical evolution by an independant evaluator using a 3-point Likert scale: better, neither better nor worse, worse. | At 3 months, at 6 months |
| Impact of the thermal cure focused on the the patient's clinical evolution self-assessed by the patient | Self-assessment by the patient of his clinical evolution, using a 3-point Likert scale: better, neither better nor worse, worse. | At 3 months, at 6 months |
| Compliance for wearing compression devices | Assessment of the compliance for wearing compression devices using the "Compression therapy" item of the VCSS (Venous Clinical Severity Score), that goes from 0 to 3. | At baseline, at 3 months, at 6 months |
| Patient satisfaction with the Saint-Eloy phlebology-oriented thermal cure | Satisfaction questionnaire with 23 items for the patients of the interventionnal arm. The passation of the questionnaire is done at the end of the thermal cure. 18 items use a numeric scale from 1 to 5 and 1 item use a numeric scale from 0 to 10. The minimal score is 18 and the maximal score is 100. The higher the score, the greater the patient satisfaction. 2 items are binary closed questions (Yes/No). Positive responses correlate with patient satisfaction. 2 items are optional open questions for positive or negative comments. | Between 3 weeks and 2 months |
| Medico-economic impact | Measurement of health care consumption and absenteeism at work through closed-ended questions. | At baseline, at 3 months, at 6 months |