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Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers

Venous Leg Ulcer Clinical Trial

Official title:
Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers: a Two-arm, Double-blind, Placebo-controlled, Randomized Controlled Trial.

Clinical Trial Summary

The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of chronic venous insufficiency ulcers has been established. This study is designed to determine the most efficient method of treatment.

Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of TR 987 gel. It is a two-arm, design: One group will receive twice-weekly applications of 0.1% TR 987 in a gel base plus SoC for the first 4 weeks. The other group will receive twice-weekly applications of placebo gel base plus SoC for the same period of time. After 4 weeks, both groups will receive once weekly applications of their assigned treatment for the remaining 8 weeks of the trial. The Standard of Care therapy in this study is multi-layer compression therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03154619
Study type Interventional
Source SerenaGroup, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 2016
Completion date April 1, 2021
View Details
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