Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: Chronic Venous Insufficiency (CVI)

Treatments: Device: V0322 BC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01402921

V00322 BC 402

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

Elastic Medical Compressive Therapy

Experimental group

Description:

V0322BC verum medical compressive therapy is a progressive compressive sock with: * ankle pressure: 10 mmHg * calf pressure : 23 mmHg

Treatment:

Device: V0322 BC

Placebo

Placebo Comparator group

Description:

V0322BC placebo medical compressive therapy is a progressive compressive sock with: * ankle pressure: \<5 mmHg * calf pressure : \<7 mmHg

Treatment:

Device: V0322 BC