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

Phase 2

Completed

• Conditions: Venous Leg Ulcers
• Interventions: Drug: Nexagon® High Dose; Drug: Nexagon® Vehicle; Drug: Nexagon® Low Dose

• Registration Number: NCT01199588
• Lead Sponsor: OcuNexus Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-13
• Study Start: 2011-05
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-29
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds
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

1. Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nexagon® High Dose	Nexagon® High Dose	Weekly applications of Nexagon® high dose in addition to compression dressings.
Nexagon® Vehicle	Nexagon® Vehicle	Weekly applications of Nexagon® Vehicle in addition to compression dressings.
Nexagon® Low Dose	Nexagon® Low Dose	Weekly applications of Nexagon® low dose in addition to compression dressings.

Primary Outcome Measures

Name	Time	Method
Surface area reduction	10 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (33)

Southern Arizona Limb Salvage Alliance; 🇺🇸 Tucson, Arizona, 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

Dunedin Hospital; 🇳🇿 Dunedin, Otago, New Zealand

Bay Area Foot Care; 🇺🇸 Castro Valley, California, United States

Josha Research; 🇿🇦 Bloemfontein, South Africa

Boland Ethical Research Group; 🇿🇦 Cape Town, South Africa

Doctor's Research Network; 🇺🇸 South Miami, Florida, United States

DRMC Wound Clinic; 🇺🇸 St. Geroge, Utah, United States

South Sydney Vascular Centre; 🇦🇺 Sydney, New South Wales, Australia

Unitas Hospital; 🇿🇦 Johannesburg, South Africa

WorthwhileClinical Trials; 🇿🇦 Johannesburg, South Africa

Diabetic Foot & Wound Treatment Center; 🇺🇸 El Centro, California, United States

Penn North Center For Advanced Wound Care; 🇺🇸 Kittaning, Pennsylvania, United States

Heidelberg Repatriation Hospital; 🇦🇺 Melbourne, Victoria, Australia

Advanced Foot Care and Clinical Research Center; 🇺🇸 Fresno, California, United States

Aung Foot Health Clinics; 🇺🇸 Tucson, Arizona, United States

Sunninghill Hospital; 🇿🇦 Johannesburg, South Africa

Randles Road Medical Centre; 🇿🇦 Durban, South Africa

Dr D. Lakha; 🇿🇦 Johannesburg, Gauteng, South Africa

Advanced Foot & Ankle Center; 🇺🇸 Las Vegas, Nevada, United States

Associated Foot and Ankle Specialists, LLC; 🇺🇸 Phoenix, Arizona, United States

Awhinatina Health; 🇳🇿 Manukau, Auckland, New Zealand

Witwatersrand University Medical School; 🇿🇦 Johannesburg, South Africa

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

St. John Wound Center; 🇺🇸 Tulsa, Oklahoma, United States

Passavant Area Hospital; 🇺🇸 Jacksonville, Illinois, United States

Saint Paul's Women's Center; 🇺🇸 Dallas, Texas, United States

Center For Advanced Wound Care; 🇺🇸 Wyomissing, Pennsylvania, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

GCT Mercantile Clinical Trial Centre; 🇿🇦 Port Elizabeth, South Africa

South Florida Wound Care Group; 🇺🇸 Tamarac, Florida, United States

Oceana Country Foot and Ankle; 🇺🇸 Toms River, New Jersey, United States