A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)

September 16, 2012 updated by: OcuNexus Therapeutics, Inc.

A Randomized, Double-Blind, Vehicle-controlled, Parallel Group, Dose-Ranging, Multi-center Study of the Efficacy and Safety of Nexagon® in the Treatment of Participants With Venous Leg Ulcers

Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.

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 (Actual)

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.
98

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

  • New Zealand
      • Auckland, New Zealand
        • District Nursing and Leg Ulcer Service A+Links Home Health
      • Auckland, New Zealand
        • Home Health Services Papakura
      • Auckland, New Zealand
        • Waitemata District Health Board
      • Christchurch, New Zealand
        • Nurse Maude
      • Dunedin, New Zealand
        • Dunedin Hosptial
      • Hamilton, New Zealand
        • Waikato Hospital
  • United States
    • California
      • San Francisco, California, United States, 94546
        • Centre for Clinical Research
      • Stockton, California, United States, 95204
        • Pacific Wound Center
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16544
        • Penn North Centers for Advanced Wound Care
      • Kittanning, Pennsylvania, United States, 16201
        • Armstrong County Memorial Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of venous leg ulceration
  2. Ankle brachial index of > 0.80 measured during screening or within three months prior to the Day -14 visit.
  3. Reference ulcer area greater than 1 cm2 and less than 25 cm2
  4. Reference ulcer present for at least 4 weeks
  5. Have an ankle circumference of greater than 18 cm
  6. Male of female patients aged 18 years or over
  7. Able to tolerate effective compression bandaging
  8. Patients able to walk independently with or without mobility aids
  9. Able and willing to give informed consent
  10. Able and willing to attend all follow up visits

Exclusion Criteria:

  1. Significant change in ulcer size in the screening period screening period
  2. Presence of a non-study ulcer within 2.0 cm of the reference ulcer
  3. Wound bed with exposed bone, tendon or fascia
  4. Patients with leg ulceration etiology other than venous insufficiency
  5. Patients who require wheel chairs for normal mobility
  6. Patients who have any ulcer (reference or non-reference) which shows signs of clinical infection
  7. Patients who have any ulcer (reference or non-reference) positive for β-hemolytic streptococcus upon culture.
  8. Patients who are unable to tolerate or comply with the standardized compression bandaging protocol specified in this protocol
  9. Female patients who are pregnant or breastfeeding.

  10. Patients who are currently taking:

    1. Pentoxifylline (Trental®)
    2. Immunosuppressive therapy
    3. Oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located
    4. Growth factors (e.g. Regranex)
    5. Cell cultures or topical skin factors

  11. Patients with:

    1. Renal insufficiency defined as an estimated GFR which is < 30 mL/min/1.7m2
    2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
    3. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
    4. HbA1c > 8.5%
    5. Hemoglobin < 10 g/dL
    6. Hematocrit < 0.30
    7. Platelet count < 100,000
  12. Patients have had a myocardial infarction within the previous 6 months or patients with unstable angina pectoris

  13. Patients with:

    1. Collagen vascular disease
    2. Severe rheumatoid arthritis
    3. Cellulitis or osteomyelitis
  14. Patients who have, or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment
  15. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, e.g., known to abuse alcohol or drugs currently or to have psychological disorders that could affect follow-up care

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

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
Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry

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
Adverse Events
Complete healing of the treated Venous Leg Ulcer
Reference ulcer wound healing as assessed by digital photographic planimetry

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.
  • Study Director: Scott Bannan, OcuNexus Therapeutics, Inc.

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.
March 1, 2009

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.
February 1, 2010

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.
May 1, 2010

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).
January 8, 2009

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.
January 9, 2009

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.
January 12, 2009

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.
September 18, 2012

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.
September 16, 2012

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.
September 1, 2012

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-001

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.

Clinical Trials on Venous Ulcer

Clinical Trials on Nexagon®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings