Peripheral Arterial Vascular Disease Clinical Trial
Official title:
Open Label Clinical Study to Assess the Clinical Safety of a New Compression Procedure in Subjects With Peripheral Arterial Vascular Disease
To assess the safety of a new compression device applied to patients with an ankle brachial pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice. Several perfusion assessments will investigate safety under reduced compression therapy.
Venous leg ulcers represent a very common clinical problem with increasing prevalence in an
aging population. It is believed that venous insufficiency is the underlying condition
responsible for 54-81% of leg ulcers. About 8% of leg ulcers are related to arterial
insufficiency and about 14% have a mixed aetiology. Compression therapy is considered the
most effective treatment for these ulcers. The overall cost of chronic venous leg ulcer is
high because long term ongoing care is required. Also the quality of life of these patients
is jeopardized due to long lasting ulcer treatments and inconvenient compression therapies.
Several compression products are available on the market and there is a large body of
literature describing the clinical benefit of different compression systems.
A new treatment approach with the new device is to have an effective working pressure
combined with a low resting pressure. A high working pressure achieved by a rigid sleeve
around a patient's leg is essential to support the muscle pump, necessary for sufficient
blood reflux. However the resting pressure could be low without relevant reduction of
compression efficacy but with an increase in safety for patients with a mild to moderate
peripheral arterial occlusive disease (PAOD). A high resting pressure is believed to be a
main reason for reduced arterial skin perfusion which can result in pressure related skin
damage. Accordingly most compression systems are not indicated for patients with an ABPI
lower than 0.8. About 25% of patients with chronic venous insufficiency suffer from PAOD and
hence are very difficult to treat with compression. With the new device, these patients
could be sufficiently treated, because a low resting pressure is believed to have low
influence on skin perfusion.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment