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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00820196




Registration number
NCT00820196
Ethics application status
Date submitted
8/01/2009
Date registered
12/01/2009
Date last updated
18/09/2012

Titles & IDs
Public title
A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
Scientific title
A Randomized, Double-Blind, Vehicle-controlled, Parallel Group, Dose-Ranging, Multi-center Study of the Efficacy and Safety of Nexagon® in the Treatment of Participants With Venous Leg Ulcers
Secondary ID [1] 0 0
NEX-ULC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Ulcer 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Complete healing of the treated Venous Leg Ulcer
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Reference ulcer wound healing as assessed by digital photographic planimetry
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Adverse Events
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
1. Diagnosis of venous leg ulceration
2. Ankle brachial index of > 0.80 measured during screening or within three months prior to the Day -14 visit.
3. Reference ulcer area greater than 1 cm2 and less than 25 cm2
4. Reference ulcer present for at least 4 weeks
5. Have an ankle circumference of greater than 18 cm
6. Male of female patients aged 18 years or over
7. Able to tolerate effective compression bandaging
8. Patients able to walk independently with or without mobility aids
9. Able and willing to give informed consent
10. Able and willing to attend all follow up visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant change in ulcer size in the screening period screening period
2. Presence of a non-study ulcer within 2.0 cm of the reference ulcer
3. Wound bed with exposed bone, tendon or fascia
4. Patients with leg ulceration etiology other than venous insufficiency
5. Patients who require wheel chairs for normal mobility
6. Patients who have any ulcer (reference or non-reference) which shows signs of clinical infection
7. Patients who have any ulcer (reference or non-reference) positive for ß-hemolytic streptococcus upon culture.
8. Patients who are unable to tolerate or comply with the standardized compression bandaging protocol specified in this protocol
9. Female patients who are pregnant or breastfeeding.
10. Patients who are currently taking:

1. Pentoxifylline (Trental®)
2. Immunosuppressive therapy
3. Oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located
4. Growth factors (e.g. Regranex)
5. Cell cultures or topical skin factors
11. Patients with:

1. Renal insufficiency defined as an estimated GFR which is < 30 mL/min/1.7m2
2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
3. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
4. HbA1c > 8.5%
5. Hemoglobin < 10 g/dL
6. Hematocrit < 0.30
7. Platelet count < 100,000
12. Patients have had a myocardial infarction within the previous 6 months or patients with unstable angina pectoris
13. Patients with:

1. Collagen vascular disease
2. Severe rheumatoid arthritis
3. Cellulitis or osteomyelitis
14. Patients who have, or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment
15. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, e.g., known to abuse alcohol or drugs currently or to have psychological disorders that could affect follow-up care

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
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
New Zealand
State/province [5] 0 0
Dunedin
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief summary
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.
Trial website
https://clinicaltrials.gov/study/NCT00820196
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott Bannan
Address 0 0
OcuNexus Therapeutics, Inc.
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/NCT00820196