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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01199588




Registration number
NCT01199588
Ethics application status
Date submitted
9/09/2010
Date registered
13/09/2010
Date last updated
1/05/2014

Titles & IDs
Public title
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
Scientific 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
Secondary ID [1] 0 0
NEX-ULC-007
Universal Trial Number (UTN)
Trial acronym
NOVEL2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcers 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nexagon® Low Dose
Treatment: Drugs - Nexagon® High Dose
Treatment: Drugs - Nexagon® Vehicle

Experimental: Nexagon® High Dose - Weekly applications of Nexagon® high dose in addition to compression dressings.

Placebo comparator: Nexagon® Vehicle - Weekly applications of Nexagon® Vehicle in addition to compression dressings.

No intervention: No Investigational Product - Weekly application of compression dressings.

Experimental: Nexagon® Low Dose - Weekly applications of Nexagon® low dose in addition to compression dressings.


Treatment: Drugs: Nexagon® Low Dose
Weekly, topical application of Nexagon® low dose used with compression dressings.

Treatment: Drugs: Nexagon® High Dose
Weekly, topical application of Nexagon® high dose used with compression dressings.

Treatment: Drugs: Nexagon® Vehicle
Weekly, topical application of Nexagon® Vehicle used with compression dressings.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Surface area reduction
Timepoint [1] 0 0
10 weeks
Secondary outcome [1] 0 0
Incidence of complete closure
Timepoint [1] 0 0
10 weeks
Secondary outcome [2] 0 0
Time to complete closure
Timepoint [2] 0 0
10 weeks
Secondary outcome [3] 0 0
Incidence of ulcer recurrence
Timepoint [3] 0 0
12 weeks post closure
Secondary outcome [4] 0 0
Pain
Timepoint [4] 0 0
10 weeks
Secondary outcome [5] 0 0
Incidence of adverse events
Timepoint [5] 0 0
10 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
South Sydney Vascular Centre - Sydney
Recruitment hospital [2] 0 0
Heidelberg Repatriation Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2228 - Sydney
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Otago
Country [14] 0 0
South Africa
State/province [14] 0 0
Gauteng
Country [15] 0 0
South Africa
State/province [15] 0 0
Bloemfontein
Country [16] 0 0
South Africa
State/province [16] 0 0
Cape Town
Country [17] 0 0
South Africa
State/province [17] 0 0
Durban
Country [18] 0 0
South Africa
State/province [18] 0 0
Johannesburg
Country [19] 0 0
South Africa
State/province [19] 0 0
Port Elizabeth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
OcuNexus Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01199588
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tom Serena, MD
Address 0 0
Penn North Centers For Advanced Wound Care, PA, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01199588