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

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: Completed
• Conditions: Venous Leg Ulcers
• Intervention / Treatment: Drug: Nexagon® High Dose; Drug: Nexagon® Vehicle; Drug: Nexagon® Low Dose

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Surface area reduction	10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain	10 weeks
Incidence of complete closure	10 weeks
Time to complete closure	10 weeks
Incidence of ulcer recurrence	12 weeks post closure
Incidence of adverse events	10 weeks

Collaborators and Investigators

• Sponsor: OcuNexus Therapeutics, Inc.
• Investigators: Principal Investigator: Tom Serena, MD, Penn North Centers For Advanced Wound Care, PA, USA

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 29, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Ulcers; wounds; Nexagon; CoDa; chronic wounds; VLU; Venous Leg Ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: NEX-ULC-007