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

Venous Leg Ulcers Clinical Trial

— NOVEL2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199588
• Other study ID #: NEX-ULC-007
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2010
• Last updated: April 29, 2014
• Start date: May 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: CoDa Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationNew Zealand: MedsafeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	Heidelberg Repatriation Hospital	Melbourne	Victoria
Australia	South Sydney Vascular Centre	Sydney	New South Wales
New Zealand	Dunedin Hospital	Dunedin	Otago
New Zealand	Awhinatina Health	Manukau	Auckland
South Africa	Josha Research	Bloemfontein
South Africa	Boland Ethical Research Group	Cape Town
South Africa	Randles Road Medical Centre	Durban
South Africa	Dr D. Lakha	Johannesburg	Gauteng
South Africa	Sunninghill Hospital	Johannesburg
South Africa	Unitas Hospital	Johannesburg
South Africa	Witwatersrand University Medical School	Johannesburg
South Africa	WorthwhileClinical Trials	Johannesburg
South Africa	GCT Mercantile Clinical Trial Centre	Port Elizabeth
United States	Bay Area Foot Care	Castro Valley	California
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Saint Paul's Women's Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Diabetic Foot & Wound Treatment Center	El Centro	California
United States	Penn North Center For Advanced Wound Care	Erie	Pennsylvania
United States	Advanced Foot Care and Clinical Research Center	Fresno	California
United States	Passavant Area Hospital	Jacksonville	Illinois
United States	Penn North Center For Advanced Wound Care	Kittaning	Pennsylvania
United States	Advanced Foot & Ankle Center	Las Vegas	Nevada
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	Associated Foot and Ankle Specialists, LLC	Phoenix	Arizona
United States	Doctor's Research Network	South Miami	Florida
United States	DRMC Wound Clinic	St. Geroge	Utah
United States	South Florida Wound Care Group	Tamarac	Florida
United States	Oceana Country Foot and Ankle	Toms River	New Jersey
United States	Aung Foot Health Clinics	Tucson	Arizona
United States	Southern Arizona Limb Salvage Alliance	Tucson	Arizona
United States	St. John Wound Center	Tulsa	Oklahoma
United States	Center For Advanced Wound Care	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CoDa Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface area reduction		10 weeks	No
Secondary	Incidence of complete closure		10 weeks	No
Secondary	Time to complete closure		10 weeks	No
Secondary	Incidence of ulcer recurrence		12 weeks post closure	No
Secondary	Pain		10 weeks	No
Secondary	Incidence of adverse events		10 weeks	Yes