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

Primary Purpose

Venous Ulcer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nexagon®
Nexagon® vehicle
Sponsored by
OcuNexus Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer focused on measuring Venous ulcer, Nexagon, CoDa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Clinical Research
  • Pacific Wound Center
  • Penn North Centers for Advanced Wound Care
  • Armstrong County Memorial Hospital
  • District Nursing and Leg Ulcer Service A+Links Home Health
  • Home Health Services Papakura
  • Waitemata District Health Board
  • Nurse Maude
  • Dunedin Hosptial
  • Waikato Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2009
Last Updated
September 16, 2012
Sponsor
OcuNexus Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00820196
Brief Title
A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OcuNexus Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer
Keywords
Venous ulcer, Nexagon, CoDa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nexagon®
Intervention Type
Drug
Intervention Name(s)
Nexagon® vehicle
Primary Outcome Measure Information:
Title
Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry
Secondary Outcome Measure Information:
Title
Complete healing of the treated Venous Leg Ulcer
Title
Reference ulcer wound healing as assessed by digital photographic planimetry
Title
Adverse Events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of venous leg ulceration Ankle brachial index of > 0.80 measured during screening or within three months prior to the Day -14 visit. Reference ulcer area greater than 1 cm2 and less than 25 cm2 Reference ulcer present for at least 4 weeks Have an ankle circumference of greater than 18 cm Male of female patients aged 18 years or over Able to tolerate effective compression bandaging Patients able to walk independently with or without mobility aids Able and willing to give informed consent Able and willing to attend all follow up visits Exclusion Criteria: Significant change in ulcer size in the screening period screening period Presence of a non-study ulcer within 2.0 cm of the reference ulcer Wound bed with exposed bone, tendon or fascia Patients with leg ulceration etiology other than venous insufficiency Patients who require wheel chairs for normal mobility Patients who have any ulcer (reference or non-reference) which shows signs of clinical infection Patients who have any ulcer (reference or non-reference) positive for β-hemolytic streptococcus upon culture. Patients who are unable to tolerate or comply with the standardized compression bandaging protocol specified in this protocol Female patients who are pregnant or breastfeeding. Patients who are currently taking: Pentoxifylline (Trental®) Immunosuppressive therapy Oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located Growth factors (e.g. Regranex) Cell cultures or topical skin factors Patients with: Renal insufficiency defined as an estimated GFR which is < 30 mL/min/1.7m2 Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L HbA1c > 8.5% Hemoglobin < 10 g/dL Hematocrit < 0.30 Platelet count < 100,000 Patients have had a myocardial infarction within the previous 6 months or patients with unstable angina pectoris Patients with: Collagen vascular disease Severe rheumatoid arthritis Cellulitis or osteomyelitis 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Bannan
Organizational Affiliation
OcuNexus Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Pacific Wound Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Penn North Centers for Advanced Wound Care
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Facility Name
Armstrong County Memorial Hospital
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States
Facility Name
District Nursing and Leg Ulcer Service A+Links Home Health
City
Auckland
Country
New Zealand
Facility Name
Home Health Services Papakura
City
Auckland
Country
New Zealand
Facility Name
Waitemata District Health Board
City
Auckland
Country
New Zealand
Facility Name
Nurse Maude
City
Christchurch
Country
New Zealand
Facility Name
Dunedin Hosptial
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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