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

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

Sponsors

Lead Sponsor: OcuNexus Therapeutics, Inc.

Source 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.

Overall Status Completed
Start Date May 2011
Completion Date March 2013
Primary Completion Date December 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Surface area reduction 10 weeks
Secondary Outcome
Measure Time Frame
Incidence of complete closure 10 weeks
Time to complete closure 10 weeks
Incidence of ulcer recurrence 12 weeks post closure
Pain 10 weeks
Incidence of adverse events 10 weeks
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nexagon® Low Dose

Description: Weekly, topical application of Nexagon® low dose used with compression dressings.

Arm Group Label: Nexagon® Low Dose

Intervention Type: Drug

Intervention Name: Nexagon® High Dose

Description: Weekly, topical application of Nexagon® high dose used with compression dressings.

Arm Group Label: Nexagon® High Dose

Intervention Type: Drug

Intervention Name: Nexagon® Vehicle

Description: Weekly, topical application of Nexagon® Vehicle used with compression dressings.

Arm Group Label: Nexagon® Vehicle

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Tom Serena, MD Principal Investigator Penn North Centers For Advanced Wound Care, PA, USA
Location
Facility:
Associated Foot and Ankle Specialists, LLC | Phoenix, Arizona, 85015, United States
Aung Foot Health Clinics | Tucson, Arizona, 85710, United States
Southern Arizona Limb Salvage Alliance | Tucson, Arizona, 85724, United States
Bay Area Foot Care | Castro Valley, California, 94546, United States
Diabetic Foot & Wound Treatment Center | El Centro, California, 92243, United States
Advanced Foot Care and Clinical Research Center | Fresno, California, 93722, United States
Doctor's Research Network | South Miami, Florida, 33143, United States
South Florida Wound Care Group | Tamarac, Florida, 33321, United States
Northwestern University Feinberg School of Medicine | Chicago, Illinois, 60611, United States
Passavant Area Hospital | Jacksonville, Illinois, 62650, United States
Advanced Foot & Ankle Center | Las Vegas, Nevada, 89119, United States
Oceana Country Foot and Ankle | Toms River, New Jersey, 08753, United States
St Luke's - Roosevelt Hospital Center Department of Surgery | New York, New York, 10025, United States
Stonybrook Univeristy Medical Center | New York, New York, 11794, United States
St. John Wound Center | Tulsa, Oklahoma, 74135, United States
Penn North Center For Advanced Wound Care | Erie, Pennsylvania, 16544, United States
Penn North Center For Advanced Wound Care | Kittaning, Pennsylvania, 16544, United States
Center For Advanced Wound Care | Wyomissing, Pennsylvania, 19610, United States
UT Southwestern Medical Center | Dallas, Texas, 75235, United States
Saint Paul's Women's Center | Dallas, Texas, 75237, United States
DRMC Wound Clinic | St. Geroge, Utah, 84770, United States
South Sydney Vascular Centre | Sydney, New South Wales, 2228, Australia
Heidelberg Repatriation Hospital | Melbourne, Victoria, Australia
Awhinatina Health | Manukau, Auckland, 2110, New Zealand
Dunedin Hospital | Dunedin, Otago, New Zealand
Dr D. Lakha | Johannesburg, Gauteng, 1829, South Africa
Josha Research | Bloemfontein, 9301, South Africa
Boland Ethical Research Group | Cape Town, 6850, South Africa
Randles Road Medical Centre | Durban, 4091, South Africa
Unitas Hospital | Johannesburg, 0157, South Africa
WorthwhileClinical Trials | Johannesburg, 1500, South Africa
Sunninghill Hospital | Johannesburg, 2157, South Africa
Witwatersrand University Medical School | Johannesburg, 2193, South Africa
GCT Mercantile Clinical Trial Centre | Port Elizabeth, 6020, South Africa
Location Countries

Australia

New Zealand

South Africa

United States

Verification Date

April 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Nexagon® High Dose

Type: Experimental

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

Label: Nexagon® Vehicle

Type: Placebo Comparator

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

Label: No Investigational Product

Type: No Intervention

Description: Weekly application of compression dressings.

Label: Nexagon® Low Dose

Type: Experimental

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

Acronym NOVEL2
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov