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

Purpose

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.

Condition	Intervention	Phase
Chronic Venous Insufficiency (CVI)	Device: V0322 BC	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Edema

U.S. FDA Resources

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:

Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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. [ Time Frame: 0-Day 7-Day 30 and Day 90 ] [ Designated as safety issue: No ]
Quality of life. SQOR-V and ABC-V (FARDEAU) score [ Time Frame: 0-Day 7-Day 30 and Day 90 ] [ Designated as safety issue: No ]
Body weight variation [ Time Frame: 0-Day 7-Day 30 and Day 90 ] [ Designated as safety issue: No ]
Suprafacial Thickness Measured Duplex measurement [ Time Frame: 0-Day 7-Day 30 and Day 90 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Elastic Medical Compressive Therapy V0322BC verum medical compressive therapy is a progressive compressive sock with: ankle pressure: 10 mmHg calf pressure : 23 mmHg	Device: 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
Placebo Comparator: Placebo V0322BC placebo medical compressive therapy is a progressive compressive sock with: ankle pressure: <5 mmHg calf pressure : <7 mmHg	Device: 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

Arms

Assigned Interventions

Experimental: Elastic Medical Compressive Therapy

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

ankle pressure: 10 mmHg
calf pressure : 23 mmHg

Device: 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

Placebo Comparator: Placebo

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

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

Device: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402921

Contacts

Contact: Patrick CARPENTIER, MD, PR

00(33)47676 ext 8960

patrick.carpentier@ujf-grenoble.fr

Locations

France
Centre Hospitalo-Universitaire Grenoble	Recruiting
Grenoble, Isère, France, 38000
Contact: Patrick CARPENTIER, MD, PR 00(33)47676 ext 8960 patrick.carpentier@ujf-grenoble.fr
Sub-Investigator: Jean-Marc DIAMAND, MD

Sponsors and Collaborators

Pierre Fabre Medicament

More Information

No publications provided

Responsible Party:	Carpentier Pr, Centre Hospitalo-Universitaire Grenoble
ClinicalTrials.gov Identifier:	NCT01402921 History of Changes
Other Study ID Numbers:	V00322 BC 402
Study First Received:	July 13, 2011
Last Updated:	July 25, 2011
Health Authority:	French Health Product Safety Agency (AFSSAPS)FRANCE':'

Additional relevant MeSH terms:

Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013