Status:
COMPLETED
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
Lead Sponsor:
OcuNexus Therapeutics, Inc.
Conditions:
Venous Leg Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01199588
Start Date
May 1 2011
End Date
March 1 2013
Last Update
May 1 2014
Active Locations (34)
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1
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015
2
Aung Foot Health Clinics
Tucson, Arizona, United States, 85710
3
Southern Arizona Limb Salvage Alliance
Tucson, Arizona, United States, 85724
4
Bay Area Foot Care
Castro Valley, California, United States, 94546