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

NCT02988063 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: OH1-16-00664
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Varithena; Polidocanol Endovenous Microfoam

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• Proportion of patients who successfully heal

  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)

  12 weeks

Study Arms (1)

Compression plus PEM

EXPERIMENTAL

Patients will receive 4-5 weeks of compression therapy, followed by treatment with 1% polidocanol endovenous microfoam (PEM) and 12 additional weeks of compression therapy. If the treating physician determines that the vein is not closed after a subjective assessment of vein patency via standard-of-care limited duplex imaging, patients will be re-treated with PEM on Day 4.

Drug: Polidocanol Endovenous Microfoam (PEM)

Interventions

Polidocanol Endovenous Microfoam (PEM) DRUG

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.

Also known as: Varithena

Compression plus PEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Active VLU with a CEAP classification of C6
• Non-healing VLU ≥ 1 month but not greater than 24 months
• In the case of more than one ulcer, the largest ulcer (compliant with study criteria) will be chosen as the study ulcer and treated in the study. Other ulcerations, if present on the same leg must be at least 2cm apart from the study ulcer.
• Demonstrable GSV insufficiency (as per the Society for Vascular Surgery \[SVS\] and the American Venous Forum \[AVF\] Guidelines) via venous insufficiency study (VIS) (11)
• VLU considered non-healing (clinically defined as ≤70% wound improvement) after a 4-5 week run-in period with compression therapy
• Venous leg ulcer size ≥ 2cm2 within the great saphenous distribution and must be visualized in one plane to allow for image collection of the entire wound in one photo by the Silhouette device.
• The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone
• The ulcer must be located below the knee
• The ulcer bed must have some viable tissues with some granulation tissue
• Able to tolerate effective compression bandaging
• Patients able to walk independently with or without mobility aids
• Ability to comprehend and sign an informed consent document and complete study questionnaires in English
• Able and willing to attend all follow up visits

You may not qualify if:

• Age \< 18 years old
• Small saphenous vein (SSV) distribution VLUs
• Patients who had previously received interventions for underlying venous disease or prior VLU treatments that would not be considered to be conservative, in the opinion of the principal investigator
• Exposed bone, tendon, or fascia
• Deep vein reflux unless clinically insignificant in comparison to superficial reflux
• Patients with leg ulceration etiology other than venous insufficiency
• Severe rheumatoid arthritis
• History of radiotherapy to the ulcer site
• Uncontrolled congestive heart failure (left or right sided heart failure)
• Receiving corticosteroids or immune suppressive therapy
• Active clinical infection of the ulcer site, however, patients may be entered into the study after successful treatment of infection
• History of collagen vascular disease
• History of known malnutrition (albumin \<3.0 g/dL)
• History of known uncontrolled diabetes \[hemoglobin A1c (HgbA1c) \>8.0%\]
• History of known arterial insufficiency \[ankle-brachial index (ABI) \<0.7, transcutaneous oxygen (tcpO2) \<35 mmHg, or toe-brachial index (TBI) \<0.4\]

Sponsors & Collaborators

• OhioHealth: lead
• BTG International Inc.: collaborator

Study Sites (1)

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Leg Ulcer; Varicose Veins; Varicose Ulcer; Gastroesophageal Reflux

Interventions

Polidocanol

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Raghu Kolluri, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Medicine Physician/System Medical Director

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: April 10, 2017
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)