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

NCT00820196 | Completed Phase 2 DMC

• 1 other identifier: NEX-ULC-001
• Study Type: interventional
• Target: 98
• Locations: 2 countries
• Sites: 10

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.

Conditions

Venous Ulcer

Keywords

Venous ulcer; Nexagon; CoDa

Outcome Measures

Primary Outcomes (1)

• Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry

Secondary Outcomes (3)

• Complete healing of the treated Venous Leg Ulcer

• Reference ulcer wound healing as assessed by digital photographic planimetry

• Adverse Events

Interventions

Nexagon® DRUG

Nexagon® vehicle DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of venous leg ulceration
• Ankle brachial index of \> 0.80 measured during screening or within three months prior to the Day -14 visit.
• Reference ulcer area greater than 1 cm2 and less than 25 cm2
• Reference ulcer present for at least 4 weeks
• Have an ankle circumference of greater than 18 cm
• Male of female patients aged 18 years or over
• Able to tolerate effective compression bandaging
• Patients able to walk independently with or without mobility aids
• Able and willing to give informed consent
• Able and willing to attend all follow up visits

You may not qualify if:

• Significant change in ulcer size in the screening period screening period
• Presence of a non-study ulcer within 2.0 cm of the reference ulcer
• Wound bed with exposed bone, tendon or fascia
• Patients with leg ulceration etiology other than venous insufficiency
• Patients who require wheel chairs for normal mobility
• Patients who have any ulcer (reference or non-reference) which shows signs of clinical infection
• Patients who have any ulcer (reference or non-reference) positive for β-hemolytic streptococcus upon culture.
• Patients who are unable to tolerate or comply with the standardized compression bandaging protocol specified in this protocol
• Female patients who are pregnant or breastfeeding.
• Patients who are currently taking:
• Pentoxifylline (Trental®)
• Immunosuppressive therapy
• Oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located
• Growth factors (e.g. Regranex)
• Cell cultures or topical skin factors

Sponsors & Collaborators

• OcuNexus Therapeutics, Inc.: lead

Study Sites (10)

Centre for Clinical Research

San Francisco, California, 94546, United States

Location

Pacific Wound Center

Stockton, California, 95204, United States

Location

Penn North Centers for Advanced Wound Care

Erie, Pennsylvania, 16544, United States

Location

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

Location

Waitemata District Health Board

Auckland, Auckland, New Zealand

Location

District Nursing and Leg Ulcer Service A+Links Home Health

Auckland, New Zealand

Location

Home Health Services Papakura

Auckland, New Zealand

Location

Nurse Maude

Christchurch, New Zealand

Location

Dunedin Hosptial

Dunedin, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Scott Bannan

  OcuNexus Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

NZ (6); US (4)