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A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers

NCT01199588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-05-01

No results posted yet for this study

Summary

This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.

Conditions

  • Venous Leg Ulcers

Interventions

DRUG

Nexagon® Low Dose

Weekly, topical application of Nexagon® low dose used with compression dressings.

DRUG

Nexagon® High Dose

Weekly, topical application of Nexagon® high dose used with compression dressings.

DRUG

Nexagon® Vehicle

Weekly, topical application of Nexagon® Vehicle used with compression dressings.

Sponsors & Collaborators

  • OcuNexus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Tom Serena, MD · Penn North Centers For Advanced Wound Care, PA, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • United States
  • Australia
  • New Zealand
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199588 on ClinicalTrials.gov