NCT03154619

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

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.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: SerenaGroup, Inc. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DRUG	0.1% TR 987	TR 987 0.1%
DRUG	Placebo gel	Placebo gel twice weekly for 4 weeks, then once weekly for 8 weeks. Gel will be applied to cover the wound cavity and wound surface to a thickness of 5 mm.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-04-04
• Completion: 2021-04-01
• First posted: 2017-05-16
• Last updated: 2020-10-22

Locations

9 sites across 1 country: United States