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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Polidocanol endovenous microfoam (PEM) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. PEM improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Ulcer healing rate
We will determine the change in ulcer healing rate following PEM treatment. Ulcer healing rate will be measured as the relative weekly change in ulcer perimeter (cm) from baseline, until either until fully healed, or up to the final active study visit at 12 weeks (whichever is sooner). Pre-treatment healing rate will be measured as the relative change in ulcer perimeter (cm) from baseline per week over the 4-5 week run-in period.
Time frame: 12 weeks
Proportion of patients who successfully heal
We will determine the proportion of patients who successfully heal by 12 weeks. "Successful" healing will be defined as complete resolution of the ulcer (0 cm), with a lack of disruption of the epithelium at the ulcer site.
Time frame: 12 weeks
Proportion of patients who experience symptomatic pulmonary embolism and deep vein thrombosis (PE and DVT, respectively) and other drug-related adverse events (AEs)
We will determine the proportion of patients who experience symptomatic pulmonary embolism and deep vein thrombosis (PE and DVT, respectively) and other drug-related adverse events (AEs) at 12 weeks (or the last active study visit if healed prior to 12 weeks). The most commonly reported drug-related AEs (occurring in ≥3% of patients) include pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, and superficial thrombophlebitis.
Time frame: 12 weeks
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