Venous Leg Ulcer Clinical Trial
Official title:
Effect of Polidocanol Endovenous Microfoam (PEM) Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in Venous Leg Ulcers (VLUs)
This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression
therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in
adults with severe venous disease of the great saphenous vein (GSV). All participants will
receive treatment with Varithena and compression therapy.
The purpose of this study is to assess whether the use of PEM to correct superficial axial
and varicose vein reflux is effective in improving healing of VLUs, over treatment with
compression alone.
Compression therapy and polidocanol endovenous microfoam (PEM) are both used for the
treatment of venous leg ulcers (VLUs), but they do so by different mechanisms.
Compression therapy applied by a wound care professional has been demonstrated to improve
healing rates in patients with existing VLUs and to reduce ulcer recurrence, and is used
consistently by treating physicians. Compression therapy consists of hosiery, tubular
bandages and bandage systems comprising two or more components, which provide graduated
compression to the lower limb in order to improve venous return and to reduce edema.
Polidocanol endovenous microfoam (PEM) is an injectable foam medication that is used to treat
symptoms of venous disease, including venous leg ulcers (VLUs). The medication
("polidocanol") is in the foam ("endovenous microfoam"). PEM is injected through a catheter
or by direct injection into the malfunctioning vein. The foam fills and treats the desired
section of the vein, thereby collapsing the diseased vein. When the malfunctioning vein
collapses, the microfoam is deactivated and blood flow shifts to healthier veins nearby.
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