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

Completed · Phase 2

Conditions studied: Venous Leg Ulcers

In brief

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.

Key facts

Study ID

NCT01199588

Run by

OcuNexus Therapeutics, Inc.

People needed

300

Starts

2011-05-01

Expected to finish

2013-03-01

Last updated by the study team

2014-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Associated Foot and Ankle Specialists, LLC — Phoenix, Arizona, United States
• Aung Foot Health Clinics — Tucson, Arizona, United States
• Southern Arizona Limb Salvage Alliance — Tucson, Arizona, United States
• Bay Area Foot Care — Castro Valley, California, United States
• Diabetic Foot & Wound Treatment Center — El Centro, California, United States
• Advanced Foot Care and Clinical Research Center — Fresno, California, United States
• Doctor's Research Network — South Miami, Florida, United States
• South Florida Wound Care Group — Tamarac, Florida, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Passavant Area Hospital — Jacksonville, Illinois, United States
• Advanced Foot & Ankle Center — Las Vegas, Nevada, United States
• Oceana Country Foot and Ankle — Toms River, New Jersey, United States
• St Luke's - Roosevelt Hospital Center Department of Surgery — New York, New York, United States
• Stonybrook Univeristy Medical Center — New York, New York, United States
• St. John Wound Center — Tulsa, Oklahoma, United States
• Penn North Center For Advanced Wound Care — Erie, Pennsylvania, United States
• Penn North Center For Advanced Wound Care — Kittaning, Pennsylvania, United States
• Center For Advanced Wound Care — Wyomissing, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Saint Paul's Women's Center — Dallas, Texas, United States
• DRMC Wound Clinic — Saint Geroge, Utah, United States
• South Sydney Vascular Centre — Sydney, New South Wales, Australia
• Heidelberg Repatriation Hospital — Melbourne, Victoria, Australia
• Awhinatina Health — Manukau, Auckland, New Zealand
• Dunedin Hospital — Dunedin, Otago, New Zealand

Full record on ClinicalTrials.gov

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