Status:
COMPLETED
Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Chronic Venous Insufficiency (CVI)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01402921
Start Date
January 1 2011
End Date
March 1 2012
Last Update
November 10 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalo-Universitaire Grenoble
Grenoble, Isère, France, 38000