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
Additional identifiers
EudraCT number
ClinicalTrials.gov 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
Acronym
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
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic venous desease (or insufficiency)
Intervention
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
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
27/06/2007
Overall trial end date
25/09/2008
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
400
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
27/06/2007
Recruitment end date
25/09/2008
Locations
Countries of recruitment
France
Trial participating centre
104 rue Bergson
Saint Etienne
42000
France
Sponsor information
Organisation
Pierre Fabre (France)
Sponsor details
c/o Mr Xavier Saudez
29 Avenue du Sidobre
Castres
81106
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pierre Fabre Laboratories (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22592040