Single-centre, Prospective, Randomised, Controlled, Study to Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles by Millet Innovation on the Symptoms and Quality of Life of Patients With Chronic Venous Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quality of life generic questionnaire
研究概览
简要总结
The main objective is to evaluate the effect of wearing the insoles developed by Millet Innovation on the symptoms and quality of life of patients suffering from chronic venous disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic venous disease at CEAP C2S stage - the S means that patients must be symptomatic
- •Women or men aged over 18
- •Good general state of health
- •High or average level of activity estimated by the GAPQ questionnaire
- •Patient able to understand the requirements of the trial and having signed a free and informed consent prior to study entry
- •Patient able to read and understand written instructions
- •Patient able to complete the self-assessment questionnaires
- •Patient with a foot size between 36 and 44
排除标准
- •Low level of activity estimated by the GAPQ questionnaire
- •Cardiac, inflammatory, liver, kidney and arterial disease
- •Subject with non-venous oedema
- •Subject with an open wound on the foot
- •Subject unable to attend all 3 visits
- •Patients unable to comply with the constraints of the protocol, in particular patients whose mental state does not allow them to understand the nature, objectives and possible consequences of the study.
- •Pregnant or breastfeeding women or women who are expecting to become pregnant during the study.
- •Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent
- •Adults subject to a legal protection measure or unable to express their consent
- •Any other reason which, in the opinion of the investigator, could interfere with the proper conduct of the study.
- •Patient unable to wear shoes with a drop of less than 2.5cm for the duration of the study
- •Subject already wearing orthopaedic insoles or standard insoles
结局指标
主要结局
Quality of life generic questionnaire
时间窗: At Day 0 then Day 30 and Day 60
The 5-level EQ-5D version (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1 point), to extreme problems (5 points). A low score indicates a low impact of the disease on quality of life. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' (100/100) and 'The worst health you can image' (0/100).
Quality of life questionnaire
时间窗: At Day 0 then Day 30 and Day 60
CIVIQ (ChronIc Venous Insufficiency quality of life Questionnaire) 14 : It is a quality of life assessment scale comprising 14 items grouped into four main dimensions (pain, physical, psychological, social) with 5 levels (1 point (min) to 5 points (max)).The final score is between 14 and 70 points. A low score indicates a low impact of the disease on quality of life.
次要结局
- Assessment of the 'ejection fraction' of the venous blood volume (ml)(At Day 0 then Day 30 and Day 60)
- Symptoms evaluation questionnaire(At Day 0 then Day 30 and Day 60)
- Leg Oedema evaluation(At Day 0 then Day 30 and Day 60)