Upward progressive versus degressive compressive stocking in patients with moderate to severe chronic venous insufficiency
| ISRCTN | ISRCTN80111329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80111329 |
| Secondary identifying numbers | V00322 BC 401 |
- Submission date
- 27/10/2011
- Registration date
- 03/01/2012
- Last edited
- 09/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
104 rue Bergson
Saint Etienne
42000
France
Study information
| Study design | Multicentre randomised double-blind parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised double-blind trial of upward progressive versus degressive compressive stocking in patients with moderate to severe chronic venous insufficiency |
| Study objectives | There is a higher impact on clinical symptoms in patients suffering moderate to severe chronic venous disease |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 27/06/2007 |
| Completion date | 25/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/06/2007 |
| Date of final enrolment | 25/09/2008 |
Locations
Countries of recruitment
- France
Study participating centre
42000
France
Sponsor information
Industry
c/o Mr Xavier Saudez
29 Avenue du Sidobre
Castres
81106
France
| Website | http://www.pierre-fabre.com/ |
|---|---|
"ROR" |
https://ror.org/04hdhz511 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | Yes | No |
