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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Pierre Fabre Medicament.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01402921
First received: July 13, 2011
Last updated: July 25, 2011
Last verified: July 2011
  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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014