Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema. International, Multicentric, Randomised, Controlled, Double Blind Study, in Two Parallel Groups v0322 bc Versus Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement)
研究概览
简要总结
Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Item C3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. Literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. It is therefore particularly relevant in a C3-patient trial (CEAP classification).
The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years and above
- •Permanent chronic oedema of venous origin (C3 based on CEAP classification) confirmed by Doppler or Duplex ultrasound examination with reflux and/or obstruction on superficial, deep or perforator veins
- •Pitting oedema
- •Have given and signed written informed consent
- •Registered with or benefiting from health insurance (Mandatory for France)
排除标准
- •Use of compression therapy in the last 5 days before inclusion
- •Common contraindications for MCT (arteriopathy, decompensated heart failure, infectious dermatitis
- •Isolated lipoedema
- •Isolated lymphoedema (Kaposi- Stemmer sign
- •Severe systemic disease (heart failure, renal failure, hepatic failure, thyroid dysfunction untreated, malnutrition with hypo-proteinemia ...)
- •Known hypersensitivity to any component of MCT
- •Important limitation of ankle movement requiring a specific therapy
- •Following treatment initiated or dose-modified 1 month prior to inclusion: NSAID, corticosteroids, calcium blockers, ACE inhibitors, Angiotensin II inhibitors, vasoconstrictors or vasodilators
- •Hormonal treatment initiated or dose-modified 1 month prior to inclusion
- •Diuretic and/or phlebotonic treatment initiated or dose-modified 1 month prior to inclusion
- •Pregnancy, breast feeding, planning to become pregnant, or not using any form of contraception
- •Patient linguistically or psychologically unable to understand the information given or who refuses to give his/her consent in writing
- •Participation in another clinical trial
- •Deprived of liberty for administrative, medical and legal reasons
- •May not be compliant with the constraints imposed by the protocol
结局指标
主要结局
Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement)
时间窗: Day 90
The main criterion is defined as the target leg volume reduction of chronic venous oedema measured by volumetry method with water displacement at 3 months
次要结局
- Quality of life. SQOR-V and ABC-V (FARDEAU) score(0-Day 7-Day 30 and Day 90)
- Body weight variation(0-Day 7-Day 30 and Day 90)
- Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)(Day 7-Day 30 and Day 90)
- Suprafacial Thickness Measured Duplex measurement(0-Day 7-Day 30 and Day 90)
- Functional symptoms by VAS (pain, heaviness) at each visit by the patient.(0-Day 7-Day 30 and Day 90)