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

Chronic Venous Insufficiency (CVI) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402921
• Other study ID #: V00322 BC 402
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2011
• Last updated: November 9, 2016
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2016
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: French Health Product Safety Agency (AFSSAPS)FRANCE':'
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency (CVI)
• Venous Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalo-Universitaire Grenoble	Grenoble	Isère

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 90	No
Secondary	Functional symptoms by VAS (pain, heaviness) at each visit by the patient.		0-Day 7-Day 30 and Day 90	No
Secondary	Quality of life. SQOR-V and ABC-V (FARDEAU) score		0-Day 7-Day 30 and Day 90	No
Secondary	Body weight variation		0-Day 7-Day 30 and Day 90	No
Secondary	Suprafacial Thickness Measured Duplex measurement		0-Day 7-Day 30 and Day 90	No
Secondary	Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)		Day 7-Day 30 and Day 90	Yes