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

NCT ID: NCT01402921

Last Updated: 2016-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

Chronic Venous Insufficiency (CVI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Elastic Medical Compressive Therapy

V0322BC verum medical compressive therapy is a progressive compressive sock with:

• ankle pressure: 10 mmHg
• calf pressure : 23 mmHg

Group Type: EXPERIMENTAL

V0322 BC

Intervention Type: DEVICE

• Stocking 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).
• The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg)
• 3 months duration daily treatment

Placebo

V0322BC placebo medical compressive therapy is a progressive compressive sock with:

• ankle pressure: <5 mmHg
• calf pressure : <7 mmHg

Group Type: PLACEBO_COMPARATOR

V0322 BC

Intervention Type: DEVICE

• Stocking 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).
• The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg)
• 3 months duration daily treatment

Interventions

V0322 BC

• Stocking 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).
• The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg)
• 3 months duration daily treatment

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalo-Universitaire Grenoble

Grenoble, Isère, France

Countries

France

Other Identifiers

V00322 BC 402

Identifier Type: -

Identifier Source: org_study_id