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

NCT02988063 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-09-15

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • BTG International Inc.

    collaborator OTHER

  • OhioHealth

    lead OTHER

Principal Investigators

  • Raghu Kolluri, MD · OhioHealth

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2017-09-12
Completion
2017-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02988063 on ClinicalTrials.gov