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

NCT01199588 | Completed Phase 2 DMC

• 1 other identifier: NEX-ULC-007
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 34

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.

Conditions

Venous Leg Ulcers

Keywords

VLU; Venous Leg Ulcers; Ulcers; chronic wounds; wounds; Nexagon; CoDa

Outcome Measures

Primary Outcomes (1)

• Surface area reduction

  10 weeks

Secondary Outcomes (5)

• Incidence of complete closure

  10 weeks

• Time to complete closure

  10 weeks

• Incidence of ulcer recurrence

  12 weeks post closure

• Pain

  10 weeks

• Incidence of adverse events

  10 weeks

Study Arms (4)

Nexagon® High Dose

EXPERIMENTAL

Weekly applications of Nexagon® high dose in addition to compression dressings.

Drug: Nexagon® High Dose

Nexagon® Vehicle

PLACEBO COMPARATOR

Weekly applications of Nexagon® Vehicle in addition to compression dressings.

Drug: Nexagon® Vehicle

No Investigational Product

NO INTERVENTION

Weekly application of compression dressings.

Nexagon® Low Dose

EXPERIMENTAL

Weekly applications of Nexagon® low dose in addition to compression dressings.

Drug: Nexagon® Low Dose

Interventions

Nexagon® Low Dose DRUG

Weekly, topical application of Nexagon® low dose used with compression dressings.

Nexagon® Low Dose

Nexagon® High Dose DRUG

Weekly, topical application of Nexagon® high dose used with compression dressings.

Nexagon® High Dose

Nexagon® Vehicle DRUG

Weekly, topical application of Nexagon® Vehicle used with compression dressings.

Nexagon® Vehicle

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OcuNexus Therapeutics, Inc.: lead

Study Sites (34)

Associated Foot and Ankle Specialists, LLC

Phoenix, Arizona, 85015, United States

Location

Aung Foot Health Clinics

Tucson, Arizona, 85710, United States

Location

Southern Arizona Limb Salvage Alliance

Tucson, Arizona, 85724, United States

Location

Bay Area Foot Care

Castro Valley, California, 94546, United States

Location

Diabetic Foot & Wound Treatment Center

El Centro, California, 92243, United States

Location

Advanced Foot Care and Clinical Research Center

Fresno, California, 93722, United States

Location

Doctor's Research Network

South Miami, Florida, 33143, United States

Location

South Florida Wound Care Group

Tamarac, Florida, 33321, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Passavant Area Hospital

Jacksonville, Illinois, 62650, United States

Location

Advanced Foot & Ankle Center

Las Vegas, Nevada, 89119, United States

Location

Oceana Country Foot and Ankle

Toms River, New Jersey, 08753, United States

Location

St Luke's - Roosevelt Hospital Center Department of Surgery

New York, New York, 10025, United States

Location

Stonybrook Univeristy Medical Center

New York, New York, 11794, United States

Location

St. John Wound Center

Tulsa, Oklahoma, 74135, United States

Location

Penn North Center For Advanced Wound Care

Erie, Pennsylvania, 16544, United States

Location

Penn North Center For Advanced Wound Care

Kittaning, Pennsylvania, 16544, United States

Location

Center For Advanced Wound Care

Wyomissing, Pennsylvania, 19610, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Saint Paul's Women's Center

Dallas, Texas, 75237, United States

Location

DRMC Wound Clinic

Saint Geroge, Utah, 84770, United States

Location

South Sydney Vascular Centre

Sydney, New South Wales, 2228, Australia

Location

Heidelberg Repatriation Hospital

Melbourne, Victoria, Australia

Location

Awhinatina Health

Manukau, Auckland, 2110, New Zealand

Location

Dunedin Hospital

Dunedin, Otago, New Zealand

Location

Dr D. Lakha

Johannesburg, Gauteng, 1829, South Africa

Location

Josha Research

Bloemfontein, 9301, South Africa

Location

Boland Ethical Research Group

Cape Town, 6850, South Africa

Location

Randles Road Medical Centre

Durban, 4091, South Africa

Location

Unitas Hospital

Johannesburg, 0157, South Africa

Location

WorthwhileClinical Trials

Johannesburg, 1500, South Africa

Location

Sunninghill Hospital

Johannesburg, 2157, South Africa

Location

Witwatersrand University Medical School

Johannesburg, 2193, South Africa

Location

GCT Mercantile Clinical Trial Centre

Port Elizabeth, 6020, South Africa

Location

MeSH Terms

Conditions

Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tom Serena, MD

  Penn North Centers For Advanced Wound Care, PA, USA

  PRINCIPAL INVESTIGATOR

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: September 9, 2010
• First Posted: September 13, 2010
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

AU (2); NZ (2); US (21); ZA (9)