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Clinical Trials/NCT01199588
NCT01199588
Completed
Phase 2

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

OcuNexus Therapeutics, Inc.33 sites in 4 countries300 target enrollmentMay 2011
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ConditionsVenous Leg Ulcers
InterventionsNexagon® High DoseNexagon® VehicleNexagon® Low Dose
DrugsNexagon® Low DoseNexagon® High DoseNexagon® Vehicle

Overview

Phase
Phase 2
Intervention
Nexagon® High Dose
Conditions
Venous Leg Ulcers
Sponsor
OcuNexus Therapeutics, Inc.
Enrollment
300
Locations
33
Primary Endpoint
Surface area reduction
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
March 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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%

Arms & Interventions

Nexagon® High Dose

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

Intervention: Nexagon® High Dose

Nexagon® Vehicle

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

Intervention: Nexagon® Vehicle

Nexagon® Low Dose

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

Intervention: Nexagon® Low Dose

Outcomes

Primary Outcomes

Surface area reduction

Time Frame: 10 weeks

Secondary Outcomes

  • Incidence of ulcer recurrence(12 weeks post closure)
  • Pain(10 weeks)
  • Incidence of adverse events(10 weeks)
  • Time to complete closure(10 weeks)
  • Incidence of complete closure(10 weeks)

Study Sites (33)

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