Clinical trial NCT01402921: Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Venous Insufficiency (CVI)
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2011-07-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement)
timeFrame: Day 90
Secondary outcomes:
measure: Functional symptoms by VAS (pain, heaviness) at each visit by the patient.
timeFrame: 0-Day 7-Day 30 and Day 90
measure: Quality of life. SQOR-V and ABC-V (FARDEAU) score
timeFrame: 0-Day 7-Day 30 and Day 90
measure: Body weight variation
timeFrame: 0-Day 7-Day 30 and Day 90
measure: Suprafacial Thickness Measured Duplex measurement
timeFrame: 0-Day 7-Day 30 and Day 90
measure: Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)
timeFrame: Day 7-Day 30 and Day 90
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalo-Universitaire Grenoble
state: Isère
Study officials:
References: