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OpenTrials
Completed

NCT Number: NCT01199588

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

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.

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Key information

Conditions

Venous Leg Ulcers Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

South Sydney Vascular Centre, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexagon® Low Dose

Drug

Weekly, topical application of Nexagon® low dose used with compression dressings.

Nexagon® High Dose

Drug

Weekly, topical application of Nexagon® high dose used with compression dressings.

Nexagon® Vehicle

Drug

Weekly, topical application of Nexagon® Vehicle used with compression dressings.

Primary outcomes

  1. Surface area reduction

    Time frame: 10 weeks

Secondary outcomes

  1. Incidence of complete closure

    Time frame: 10 weeks

  2. Time to complete closure

    Time frame: 10 weeks

  3. Incidence of ulcer recurrence

    Time frame: 12 weeks post closure

  4. Pain

    Time frame: 10 weeks

  5. Incidence of adverse events

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

OcuNexus Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: NOVEL2

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 13, 2010
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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