Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic venous insufficiency is a medical condition where the veins cannot pump enough blood back to the heart. The disease mainly occurs in the legs and more commonly affects women. The symptoms of this disease include pain, swelling and redness of the legs. The main complications are ulcers and skin diseases. Treatment includes the wearing of special stockings which compress the legs. There are different types of stockings which exert different pressures on the legs. The aim of this study is to compare the effectiveness and tolerability of two types of stockings, one where the pressure increases from the ankle to the knee (progressive), and one where the pressure decreases from the ankle to the knee (degressive).

Who can participate?
Adult patients with moderate chronic venous insufficiency.

What does the study involve?
Participants are randomly allocated to wear one of the two types of stocking.

What are the possible benefits and risks of participating?
Should the new progressive type of stocking be more effective and/or better tolerated than the degressive stockings, patients in this group will have a better treatment. In the degressive group there will be no disadvantage since the patients will receive the usual treatment. In addition, as in any study the patients will be followed up more closely and the stockings will be given for free. There could be local discomfort such as constriction and skin irritation in both groups.

Where is the study run from?
Pierre Fabre Laboratories (France).

When is the study starting and how long is it expected to run for?
June 2007 to September 2008.

Who is funding the study?
Pierre Fabre Laboratories (France).

Who is the main contact?
Dr Serge Couzan

Trial website

Contact information



Primary contact

Dr Serge Couzan


Contact details

104 rue Bergson
Saint Etienne

Additional identifiers

EudraCT number number

Protocol/serial number

V00322 BC 401

Study information

Scientific title

A randomised double-blind trial of upward progressive versus degressive compressive stocking in patients with moderate to severe chronic venous insufficiency


Study hypothesis

There is a higher impact on clinical symptoms in patients suffering moderate to severe chronic venous disease

Ethics approval

Committee to Protect People "Southeast I", University Hospital of Saint-Etienne [Comité de Protection des Personnes "Sud-Est I", Centre Hospitalier Universitaire de Saint-Etienne], 12/03/2007, ref: 2007-11 JV 2007/97

Study design

Multicentre randomised double-blind parallel-group study

Primary study design


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Chronic venous desease (or insufficiency)


Group Progressive NS : progressive compressive stockings (10 mmHg at ankle, 23 mmHg at upper calf)

For each of treatment arms the method and frequency of administration, and the total duration of treatment and follow-up products wear every day (weak-up to sleep) during 6 months

Intervention type



Not Applicable

Drug names

Primary outcome measures

Evaluation after three months of treatment - improvement of pain or heavy legs, without onset of either ulcer, deep or superficial vein thrombosis of the lower limb, or pulmonary embolism.

Secondary outcome measures

1. Compliance
2. Easiness of use
3. Discomfort/harm related to the compressive stockings at months one, three and six
4. Improvement or worsening of pain or heavy legs was evaluated using four-level Likert scales
5. Interviews concerning intercurrent venous or adverse events, compliance, easiness to apply, and discomfort/harm related to the stockings.
6. At month three, a physical examination was performed and CEAP and modified Venous Clinical Severity Score (VCSS) were evaluated

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Male or female adult outpatients
2. Presenting current pain and/or heavy legs due to moderate to severe chronic venous insufficiency (CEAP C2b to C5)
3. Eligible for a 30 mmHg compressive therapy

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Bandage therapy recommended
2. Current use of a compressive stocking >30 mmHg
3. Active ulcer
4. Deep vein thrombosis or pulmonary embolism in the past three months
5. Arterial disease of the lower limb
6. Non-venous oedema
7. Inflammatory, dermatologic or traumatic disorder of a lower limb
8. Known hypersensitivity to components of the study compressive stockings
9. Surgery or vascular procedure in the past month or planned in the next three months
10. Poor life expectancy
11. Inability to walk
12. Pregnancy

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

104 rue Bergson
Saint Etienne

Sponsor information


Pierre Fabre (France)

Sponsor details

c/o Mr Xavier Saudez
29 Avenue du Sidobre

Sponsor type




Funder type


Funder name

Pierre Fabre Laboratories (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in:

Publication citations

Additional files

Editorial Notes