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NCT03154619 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Venous Leg Ulcer, sponsored by SerenaGroup.

Active
Registry status
Phase 2
Development phase
80
Enrollment target
9
Study locations

NCT03154619 is a Phase 2 study of Venous Leg Ulcer that is active but no longer recruiting, run by SerenaGroup. The registered enrollment target is 80 participants, below the 243-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (67% lower). The trial reports 9 study locations across 5 states.

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The verdict

NCT03154619, a Phase 2 study of Venous Leg Ulcer, is active but no longer recruiting, sponsored by SerenaGroup.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
9
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo gel
  • DRUG 0.1% TR 987

Study Locations (9)

Pennsylvania

  • The Foot and Ankle Wellness Center - Ford City
  • Armstrong County Memorial Hospital - Kittanning
  • SerenaGroup Research Institute - Pittsburgh
  • Martin Foot and Ankle - York

Florida

  • Barry University Clinical Research - North Miami Beach
  • Royal Research Corp - Pembroke Pines

California

  • New Hope Podiatry Clinic - Los Angeles

New Jersey

  • Deborah Heart and Lung Center - Browns Mills

Ohio

  • Cleveland Foot and Ankle Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2016-11
Est. Completion 2021-04-01
Phase Phase 2

Sponsor

SerenaGroup

10 total trials

What the Registry Record Tells You About NCT03154619

The ClinicalTrials.gov registry entry for NCT03154619 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 243-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (67% lower). The listed sponsor is SerenaGroup, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Venous Leg Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Placebo gel is the first listed.

NCT03154619 reports 9 study locations spanning 5 distinct geographic areas - top geographies include Pennsylvania, Florida, California.

Frequently Asked Questions

What is clinical trial NCT03154619 about?

NCT03154619 is a clinical study titled "Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers". 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.

What is the current status of trial NCT03154619?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2016-11. Estimated completion is 2021-04-01.

What conditions does trial NCT03154619 study?

This clinical trial studies the following conditions: Venous Leg Ulcer.

What interventions are being tested in trial NCT03154619?

The interventions under investigation include: Placebo gel (DRUG), 0.1% TR 987 (DRUG).

Who is sponsoring clinical trial NCT03154619?

This trial is sponsored by SerenaGroup, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03154619 being conducted?

This trial has 9 study locations across California, Florida, New Jersey, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.