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

Purpose

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.

Condition	Intervention	Phase
Venous Leg Ulcers	Drug: Nexagon® Low Dose Drug: Nexagon® High Dose Drug: Nexagon® Vehicle	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders

U.S. FDA Resources

Further study details as provided by CoDa Therapeutics Inc.:

Primary Outcome Measures:

Surface area reduction [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of complete closure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Time to complete closure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Incidence of ulcer recurrence [ Time Frame: 12 weeks post closure ] [ Designated as safety issue: No ]
Pain [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	300
Study Start Date:	May 2011
Study Completion Date:	March 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nexagon® High Dose Weekly applications of Nexagon® high dose in addition to compression dressings.	Drug: Nexagon® High Dose Weekly, topical application of Nexagon® high dose used with compression dressings.
Placebo Comparator: Nexagon® Vehicle Weekly applications of Nexagon® Vehicle in addition to compression dressings.	Drug: Nexagon® Vehicle Weekly, topical application of Nexagon® Vehicle used with 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.	Drug: Nexagon® Low Dose Weekly, topical application of Nexagon® low dose used with compression dressings.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds
Ankle brachial index of > 0.80
Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2
Compliant with and able to tolerate high compression bandaging
VLU present for > 30 days prior to study entry
VLU is full thickness
The subject is willing and able to give informed consent

Exclusion Criteria:

Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
More than 75% of the VLU is on or below the malleolus
Presence of a non-study ulcer within 1.5 cm of the VLU
A VLU which shows signs of clinical infection or has cellulitis
The VLU wound bed has exposed bone, tendon or fascia
BMI > 45.0 kg/m2
Subject is not ambulatory
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
Cancerous cells in the VLU
HbA1c >10%
Blood biochemistry >3x upper limit of normal
Heart failure NYHA class III or IV
Subjects on renal replacement therapy
Immunocompromized subjects

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199588

Show 34 Study Locations

Sponsors and Collaborators

CoDa Therapeutics Inc.

Investigators


Principal Investigator:	Tom Serena, MD	Penn North Centers For Advanced Wound Care, PA, USA

More Information


Responsible Party:	CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT01199588 History of Changes
Other Study ID Numbers:	NEX-ULC-007
Study First Received:	September 9, 2010
Last Updated:	April 29, 2014
Health Authority:	United States: Food and Drug Administration New Zealand: Medsafe Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CoDa Therapeutics Inc.:


VLU Venous Leg Ulcers Ulcers chronic wounds	wounds Nexagon CoDa

Additional relevant MeSH terms:


Ulcer Leg Ulcer Varicose Ulcer Pathologic Processes Skin Ulcer	Skin Diseases Varicose Veins Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016

A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (NOVEL2)