NCT02988063

Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs

Effect of Polidocanol Endovenous Microfoam (PEM) Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in Venous Leg Ulcers (VLUs)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OhioHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leg Ulcer
• Veins, Varicose
• Venous Ulcer
• Reflux
• Venous Reflux
• Venous Leg Ulcer
• Varicose Veins
• Varicose Ulcer
• Varicose Veins Leg

Interventions

Type	Name	Description
DRUG	Polidocanol Endovenous Microfoam (PEM)	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.

Timeline

• Start date: 2017-04-10
• Primary completion: 2017-09-12
• Completion: 2017-09-12
• First posted: 2016-12-09
• Last updated: 2017-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study