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

Primary Purpose

Chronic Venous Insufficiency (CVI)

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

V0322 BC

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency (CVI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Centre Hospitalo-Universitaire Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Elastic Medical Compressive Therapy

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement)

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

Secondary Outcome Measures

Functional symptoms by VAS (pain, heaviness) at each visit by the patient.

Quality of life. SQOR-V and ABC-V (FARDEAU) score

Body weight variation

Suprafacial Thickness Measured Duplex measurement

Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)

Full Information

NCT ID

NCT01402921

First Posted

July 13, 2011

Last Updated

November 9, 2016

Sponsor

Pierre Fabre Medicament

1. Study Identification

Unique Protocol Identification Number

NCT01402921

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Medicament

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Venous Insufficiency (CVI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elastic Medical Compressive Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

V0322 BC

Intervention Description

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

Primary Outcome Measure Information:

Title

Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement)

Description

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

Time Frame

Day 90

Secondary Outcome Measure Information:

Title

Functional symptoms by VAS (pain, heaviness) at each visit by the patient.

Time Frame

0-Day 7-Day 30 and Day 90

Title

Quality of life. SQOR-V and ABC-V (FARDEAU) score

Time Frame

0-Day 7-Day 30 and Day 90

Title

Body weight variation

Time Frame

0-Day 7-Day 30 and Day 90

Title

Suprafacial Thickness Measured Duplex measurement

Time Frame

0-Day 7-Day 30 and Day 90

Title

Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)

Time Frame

Day 7-Day 30 and Day 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Centre Hospitalo-Universitaire Grenoble

City

Grenoble

State/Province

Isère

ZIP/Postal Code

38000

Country

France

12. IPD Sharing Statement

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

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