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

NCT01402921 | Completed Phase 3

• 1 other identifier: V00322 BC 402
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Venous Insufficiency (CVI)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

  0-Day 7-Day 30 and Day 90

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

  0-Day 7-Day 30 and Day 90

• Body weight variation

  0-Day 7-Day 30 and Day 90

• Suprafacial Thickness Measured Duplex measurement

  0-Day 7-Day 30 and Day 90

• Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)

  Day 7-Day 30 and Day 90

Study Arms (2)

Elastic Medical Compressive Therapy

EXPERIMENTAL

V0322BC verum medical compressive therapy is a progressive compressive sock with: * ankle pressure: 10 mmHg * calf pressure : 23 mmHg

Device: V0322 BC

Placebo

PLACEBO COMPARATOR

V0322BC placebo medical compressive therapy is a progressive compressive sock with: * ankle pressure: \<5 mmHg * calf pressure : \<7 mmHg

Device: V0322 BC

Interventions

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

Elastic Medical Compressive Therapy; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (1)

Centre Hospitalo-Universitaire Grenoble

Grenoble, Isère, 38000, France

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 26, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

FR (1)