A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (NOVEL2)

April 29, 2014 updated by: OcuNexus Therapeutics, Inc.

A Randomized, Parallel Group, Dose-Ranging, Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nexagon® in the Treatment of Subjects With a Venous Leg Ulcer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2228
        • South Sydney Vascular Centre
    • Victoria
      • Melbourne, Victoria, Australia
        • Heidelberg Repatriation Hospital
  • New Zealand
    • Auckland
      • Manukau, Auckland, New Zealand, 2110
        • Awhinatina Health
    • Otago
      • Dunedin, Otago, New Zealand
        • Dunedin Hospital
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Josha Research
      • Cape Town, South Africa, 6850
        • Boland Ethical Research Group
      • Durban, South Africa, 4091
        • Randles Road Medical Centre
      • Johannesburg, South Africa, 0157
        • Unitas Hospital
      • Johannesburg, South Africa, 1500
        • WorthwhileClinical Trials
      • Johannesburg, South Africa, 2157
        • Sunninghill Hospital
      • Johannesburg, South Africa, 2193
        • Witwatersrand University Medical School
      • Port Elizabeth, South Africa, 6020
        • GCT Mercantile Clinical Trial Centre
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Dr D. Lakha
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Associated Foot and Ankle Specialists, LLC
      • Tucson, Arizona, United States, 85710
        • Aung Foot Health Clinics
      • Tucson, Arizona, United States, 85724
        • Southern Arizona Limb Salvage Alliance
    • California
      • Castro Valley, California, United States, 94546
        • Bay Area Foot Care
      • El Centro, California, United States, 92243
        • Diabetic Foot & Wound Treatment Center
      • Fresno, California, United States, 93722
        • Advanced Foot Care And Clinical Research Center
    • Florida
      • South Miami, Florida, United States, 33143
        • Doctor's Research Network
      • Tamarac, Florida, United States, 33321
        • South Florida Wound Care Group
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Jacksonville, Illinois, United States, 62650
        • Passavant Area Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Advanced Foot & Ankle Center
    • New Jersey
      • Toms River, New Jersey, United States, 08753
        • Oceana Country Foot and Ankle
    • New York
      • New York, New York, United States, 10025
        • St Luke's - Roosevelt Hospital Center Department of Surgery
      • New York, New York, United States, 11794
        • Stonybrook Univeristy Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • St. John Wound Center
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16544
        • Penn North Center For Advanced Wound Care
      • Kittaning, Pennsylvania, United States, 16544
        • Penn North Center For Advanced Wound Care
      • Wyomissing, Pennsylvania, United States, 19610
        • Center for Advanced Wound Care
    • Texas
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75237
        • Saint Paul's Women's Center
    • Utah
      • St. Geroge, Utah, United States, 84770
        • DRMC Wound Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds
  2. Ankle brachial index of > 0.80
  3. Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2
  4. Compliant with and able to tolerate high compression bandaging
  5. VLU present for > 30 days prior to study entry
  6. VLU is full thickness
  7. The subject is willing and able to give informed consent

Exclusion Criteria:

  1. Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
  2. More than 75% of the VLU is on or below the malleolus
  3. Presence of a non-study ulcer within 1.5 cm of the VLU
  4. A VLU which shows signs of clinical infection or has cellulitis
  5. The VLU wound bed has exposed bone, tendon or fascia
  6. BMI > 45.0 kg/m2
  7. Subject is not ambulatory
  8. Subjects who have a past or present disease that, which as judged by the Investigator, may affect the safety of the subject or the outcome of the study
  9. Cancerous cells in the VLU
  10. HbA1c >10%
  11. Blood biochemistry >3x upper limit of normal
  12. Heart failure NYHA class III or IV
  13. Subjects on renal replacement therapy
  14. Immunocompromized subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nexagon® High Dose
Weekly applications of Nexagon® high dose in addition to compression dressings.
Drug: Nexagon® High Dose
Weekly, topical application of Nexagon® high dose used with compression dressings.
Placebo Comparator: Nexagon® Vehicle
Weekly applications of Nexagon® Vehicle in addition to compression dressings.
Drug: Nexagon® Vehicle
Weekly, topical application of Nexagon® Vehicle used with compression dressings.
No Intervention: No Investigational Product
Weekly application of compression dressings.
Experimental: Nexagon® Low Dose
Weekly applications of Nexagon® low dose in addition to compression dressings.
Drug: Nexagon® Low Dose
Weekly, topical application of Nexagon® low dose used with compression dressings.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Surface area reduction
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pain
Time Frame: 10 weeks
10 weeks
Incidence of complete closure
Time Frame: 10 weeks
10 weeks
Time to complete closure
Time Frame: 10 weeks
10 weeks
Incidence of ulcer recurrence
Time Frame: 12 weeks post closure
12 weeks post closure
Incidence of adverse events
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OcuNexus Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tom Serena, MD, Penn North Centers For Advanced Wound Care, PA, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEX-ULC-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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