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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 (NOVEL2)

Primary Purpose

Venous Leg Ulcers

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

About this trial

This is an interventional treatment trial for Venous Leg Ulcers focused on measuring VLU, Venous Leg Ulcers, Ulcers, chronic wounds, wounds, Nexagon, CoDa

Eligibility Criteria

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

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

Sites / Locations

  • Associated Foot and Ankle Specialists, LLC
  • Aung Foot Health Clinics
  • Southern Arizona Limb Salvage Alliance
  • Bay Area Foot Care
  • Diabetic Foot & Wound Treatment Center
  • Advanced Foot Care and Clinical Research Center
  • Doctor's Research Network
  • South Florida Wound Care Group
  • Northwestern University Feinberg School of Medicine
  • Passavant Area Hospital
  • Advanced Foot & Ankle Center
  • Oceana Country Foot and Ankle
  • St Luke's - Roosevelt Hospital Center Department of Surgery
  • Stonybrook Univeristy Medical Center
  • St. John Wound Center
  • Penn North Center For Advanced Wound Care
  • Penn North Center For Advanced Wound Care
  • Center For Advanced Wound Care
  • UT Southwestern Medical Center
  • Saint Paul's Women's Center
  • DRMC Wound Clinic
  • South Sydney Vascular Centre
  • Heidelberg Repatriation Hospital
  • Awhinatina Health
  • Dunedin Hospital
  • Dr D. Lakha
  • Josha Research
  • Boland Ethical Research Group
  • Randles Road Medical Centre
  • Unitas Hospital
  • WorthwhileClinical Trials
  • Sunninghill Hospital
  • Witwatersrand University Medical School
  • GCT Mercantile Clinical Trial Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

No Intervention

Experimental

Arm Label

Nexagon® High Dose

Nexagon® Vehicle

No Investigational Product

Nexagon® Low Dose

Arm Description

Weekly applications of Nexagon® high dose in addition to compression dressings.

Weekly applications of Nexagon® Vehicle in addition to compression dressings.

Weekly application of compression dressings.

Weekly applications of Nexagon® low dose in addition to compression dressings.

Outcomes

Primary Outcome Measures

Surface area reduction

Secondary Outcome Measures

Incidence of complete closure
Time to complete closure
Incidence of ulcer recurrence
Pain
Incidence of adverse events

Full Information

First Posted
September 9, 2010
Last Updated
April 29, 2014
Sponsor
OcuNexus Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01199588
Brief Title
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
Acronym
NOVEL2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers
Keywords
VLU, Venous Leg Ulcers, Ulcers, chronic wounds, wounds, Nexagon, CoDa

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Nexagon® High Dose
Arm Type
Experimental
Arm Description
Weekly applications of Nexagon® high dose in addition to compression dressings.
Arm Title
Nexagon® Vehicle
Arm Type
Placebo Comparator
Arm Description
Weekly applications of Nexagon® Vehicle in addition to compression dressings.
Arm Title
No Investigational Product
Arm Type
No Intervention
Arm Description
Weekly application of compression dressings.
Arm Title
Nexagon® Low Dose
Arm Type
Experimental
Arm Description
Weekly applications of Nexagon® low dose in addition to compression dressings.
Intervention Type
Drug
Intervention Name(s)
Nexagon® Low Dose
Intervention Description
Weekly, topical application of Nexagon® low dose used with compression dressings.
Intervention Type
Drug
Intervention Name(s)
Nexagon® High Dose
Intervention Description
Weekly, topical application of Nexagon® high dose used with compression dressings.
Intervention Type
Drug
Intervention Name(s)
Nexagon® Vehicle
Intervention Description
Weekly, topical application of Nexagon® Vehicle used with compression dressings.
Primary Outcome Measure Information:
Title
Surface area reduction
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Incidence of complete closure
Time Frame
10 weeks
Title
Time to complete closure
Time Frame
10 weeks
Title
Incidence of ulcer recurrence
Time Frame
12 weeks post closure
Title
Pain
Time Frame
10 weeks
Title
Incidence of adverse events
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds Ankle brachial index of > 0.80 Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2 Compliant with and able to tolerate high compression bandaging VLU present for > 30 days prior to study entry VLU is full thickness The subject is willing and able to give informed consent Exclusion Criteria: Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period More than 75% of the VLU is on or below the malleolus Presence of a non-study ulcer within 1.5 cm of the VLU A VLU which shows signs of clinical infection or has cellulitis The VLU wound bed has exposed bone, tendon or fascia BMI > 45.0 kg/m2 Subject is not ambulatory 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 Cancerous cells in the VLU HbA1c >10% Blood biochemistry >3x upper limit of normal Heart failure NYHA class III or IV Subjects on renal replacement therapy Immunocompromized subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Serena, MD
Organizational Affiliation
Penn North Centers For Advanced Wound Care, PA, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associated Foot and Ankle Specialists, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Aung Foot Health Clinics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Southern Arizona Limb Salvage Alliance
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Bay Area Foot Care
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Diabetic Foot & Wound Treatment Center
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Advanced Foot Care and Clinical Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93722
Country
United States
Facility Name
Doctor's Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
South Florida Wound Care Group
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Passavant Area Hospital
City
Jacksonville
State/Province
Illinois
ZIP/Postal Code
62650
Country
United States
Facility Name
Advanced Foot & Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Oceana Country Foot and Ankle
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08753
Country
United States
Facility Name
St Luke's - Roosevelt Hospital Center Department of Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Stonybrook Univeristy Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
St. John Wound Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Penn North Center For Advanced Wound Care
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Facility Name
Penn North Center For Advanced Wound Care
City
Kittaning
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States
Facility Name
Center For Advanced Wound Care
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Saint Paul's Women's Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
DRMC Wound Clinic
City
St. Geroge
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
South Sydney Vascular Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2228
Country
Australia
Facility Name
Heidelberg Repatriation Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Awhinatina Health
City
Manukau
State/Province
Auckland
ZIP/Postal Code
2110
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
State/Province
Otago
Country
New Zealand
Facility Name
Dr D. Lakha
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Boland Ethical Research Group
City
Cape Town
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Randles Road Medical Centre
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Unitas Hospital
City
Johannesburg
ZIP/Postal Code
0157
Country
South Africa
Facility Name
WorthwhileClinical Trials
City
Johannesburg
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Sunninghill Hospital
City
Johannesburg
ZIP/Postal Code
2157
Country
South Africa
Facility Name
Witwatersrand University Medical School
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
GCT Mercantile Clinical Trial Centre
City
Port Elizabeth
ZIP/Postal Code
6020
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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