Last updated on December 2017

A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial


Brief description of study

A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial

Detailed Study Description

This study is a multi-center, randomized, double blind, placebo-controlled dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be used as SC in this study.

The study will have three (3) phases: Screening (2 weeks), Treatment Phase (13 weeks, with treatment up to 12 weeks) and Follow-Up (12 weeks).

Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease) in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either the Active Treatment (VF001-DP low or high dose plus SC) or the Control Treatment (Placebo plus SC) in a ratio of 1:1:1.

Clinical Study Identifier: TX146476

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University of Miami Hospital

Located in: Miami, FL USA
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Spotlight Research Center

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