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NCT Number: NCT01402921

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

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.

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Key information

Conditions

Chronic Venous Insufficiency (CVI)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalo-Universitaire Grenoble

Grenoble, Isère, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V0322 BC

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

Primary outcomes

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

    Time frame: Day 90

    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 outcomes

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

    Time frame: 0-Day 7-Day 30 and Day 90

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

    Time frame: 0-Day 7-Day 30 and Day 90

  3. Body weight variation

    Time frame: 0-Day 7-Day 30 and Day 90

  4. Suprafacial Thickness Measured Duplex measurement

    Time frame: 0-Day 7-Day 30 and Day 90

  5. 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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2011
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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