In chronic venous insufficiency (CVI), the venous system of the legs is ineffective in
performing venous return, and there is venous reflux due to valve failure, physical
inactivity and cardiovascular problems, leading to an increase in the pressure in the veins
and venous hypertension. Chronic venous insufficiency includes a range of signs and symptoms,
including varicose veins, varicose veins, oedema, skin lesions and ulcers.
Venous ulcers are wounds that occur due to improper functioning of venous valves secondary to
severe chronic venous insufficiency. They are mainly located in the internal lateral zone of
the distal third of the leg. Ulcers of venous aetiology make up 80% of all ulcers. They have
an incidence of between 15 to 30 per 100'000 personyears.
The median healing time for chronic venous ulcers approximates 180 days. These ulcers may
produce a foul-smelling discharge, can become infected and cause pain, which, in combination
with slow healing and frequent relapses, affects the quality of life of affected patients.
The treatment of chronic venous ulcers requires a comprehensive approach for the patient,
addressing the etiological factors that determine their evolution, such as venous
insufficiency, diet, physical inactivity and postural measures. Local treatment has two
components: local ulcer healing and control of venous insufficiency by means of compression
therapy.
There is evidence that compression therapy promotes the healing process of venous ulcers.
However, there is a large number of compression garments available and it is unclear which
method of compression is the most effective. Traditionally, multilayered compression banding
was the first line management for uncomplicated venous ulcers. This serves to increase venous
return and reduce venous hypertension, as well as reduce oedema and improve lymphatic
circulation. Despite its importance and widespread use, it has been reported that ca. 50% of
patients do not comply with their multilevel bandaging. Reasons for non-compliance are skin
irritation, bandage slippage, pain, malodor, inability to maintain hygiene, and discomfort
and inability to wear normal footwear. Over recent years, there has been development of
several Velcro-based wrap devices for use as alternative compression bandaging for venous
ulcer management, using either interlacing or overlapping technique of wrapping. Systematic
reviews have been undertaken for Velcro wrap devices, including their use in chronic edema,
lipedema, and lymphedema, as well as venous ulceration. These systematic reviews were able to
show a reduction in limb volume and more consistent sub-bandage pressure in Velcro wrap
devices compared with bandaging. In addition, one of the major advantages that was reported
was the relative ease to remove and reapply these devices, which can, therefore, encourage
self-care, improve independence and, potentially, quality of life.
The Compreflex standard calf and foot (with basic liner) from Sigvaris (St. Gallen,
Switzerland) is an easy to use interlacing Velcro wrap device with adjustable compression
levels.This Compreflex wrap is intended for patients with mild to moderate lymphedema and
venous insufficiency. More than 200'000 products have been sold worldwide since 2016. The
product is being used in many European countries (including United Kingdom, Switzerland,
Netherland), United States of America, Saudi Arabia, India, Indonesia, Taiwan and Hong Kong,
with no product-related safety issues reported. Although the product is not substantially
different from other established products that are already available on the market, there are
no clinical data published on Compreflex.
The present study was therefore designed to confirm the performance of the Compreflex
standard calf and foot (with basic liner).