A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)

Venous Ulcer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820196
• Other study ID #: NEX-ULC-001
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2009
• Last updated: September 16, 2012
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2012
• Source: CoDa Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: MedsafeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

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

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Drug:
• Nexagon®

• Nexagon® vehicle

Locations

Country	Name	City	State
New Zealand	District Nursing and Leg Ulcer Service A+Links Home Health	Auckland
New Zealand	Home Health Services Papakura	Auckland
New Zealand	Waitemata District Health Board	Auckland
New Zealand	Nurse Maude	Christchurch
New Zealand	Dunedin Hosptial	Dunedin
New Zealand	Waikato Hospital	Hamilton
United States	Penn North Centers for Advanced Wound Care	Erie	Pennsylvania
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	Centre for Clinical Research	San Francisco	California
United States	Pacific Wound Center	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
CoDa Therapeutics Inc.

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry			No
Secondary	Complete healing of the treated Venous Leg Ulcer			No
Secondary	Reference ulcer wound healing as assessed by digital photographic planimetry			No
Secondary	Adverse Events			Yes