A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
NCT ID: NCT01199588
Last Updated: 2014-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2011-05-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
NCT00820196
A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)
NCT01490879
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
NCT00820703
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
NCT00736593
Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers
NCT06930768
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nexagon® High Dose
Weekly applications of Nexagon® high dose in addition to compression dressings.
Nexagon® High Dose
Weekly, topical application of Nexagon® high dose used with compression dressings.
Nexagon® Vehicle
Weekly applications of Nexagon® Vehicle in addition to compression dressings.
Nexagon® Vehicle
Weekly, topical application of Nexagon® Vehicle used with compression dressings.
No Investigational Product
Weekly application of compression dressings.
No interventions assigned to this group
Nexagon® Low Dose
Weekly applications of Nexagon® low dose in addition to compression dressings.
Nexagon® Low Dose
Weekly, topical application of Nexagon® low dose used with compression dressings.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nexagon® Low Dose
Weekly, topical application of Nexagon® low dose used with compression dressings.
Nexagon® High Dose
Weekly, topical application of Nexagon® high dose used with compression dressings.
Nexagon® Vehicle
Weekly, topical application of Nexagon® Vehicle used with compression dressings.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
OcuNexus Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tom Serena, MD
Role: PRINCIPAL_INVESTIGATOR
Penn North Centers For Advanced Wound Care, PA, USA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Dr D. Lakha
Johannesburg, Gauteng, South Africa
Josha Research
Bloemfontein, , South Africa
Boland Ethical Research Group
Cape Town, , South Africa
Randles Road Medical Centre
Durban, , South Africa
Unitas Hospital
Johannesburg, , South Africa
WorthwhileClinical Trials
Johannesburg, , South Africa
Sunninghill Hospital
Johannesburg, , South Africa
Witwatersrand University Medical School
Johannesburg, , South Africa
GCT Mercantile Clinical Trial Centre
Port Elizabeth, , South Africa
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEX-ULC-007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.