Clinical trial NCT01199588: A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Leg Ulcers
Keywords: VLU
Venous Leg Ulcers
Ulcers
chronic wounds
wounds
Nexagon
CoDa
Lead sponsor: OcuNexus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
2. More than 75% of the VLU is on or below the malleolus
3. Presence of a non-study ulcer within 1.5 cm of the VLU
4. A VLU which shows signs of clinical infection or has cellulitis
5. The VLU wound bed has exposed bone, tendon or fascia
6. BMI \> 45.0 kg/m2
7. Subject is not ambulatory
8. 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
9. Cancerous cells in the VLU
10. HbA1c \>10%
11. Blood biochemistry \>3x upper limit of normal
12. Heart failure NYHA class III or IV
13. Subjects on renal replacement therapy
14. Immunocompromized subjects

Primary outcomes:
measure: Surface area reduction
timeFrame: 10 weeks
Secondary outcomes:
measure: Incidence of complete closure
timeFrame: 10 weeks
measure: Time to complete closure
timeFrame: 10 weeks
measure: Incidence of ulcer recurrence
timeFrame: 12 weeks post closure
measure: Pain
timeFrame: 10 weeks
measure: Incidence of adverse events
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Foot and Ankle Specialists, LLC
state: Arizona
city: Tucson
country: United States
facility: Aung Foot Health Clinics
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona Limb Salvage Alliance
state: Arizona
city: Castro Valley
country: United States
facility: Bay Area Foot Care
state: California
city: El Centro
country: United States
facility: Diabetic Foot & Wound Treatment Center
state: California
city: Fresno
country: United States
facility: Advanced Foot Care and Clinical Research Center
state: California
city: South Miami
country: United States
facility: Doctor's Research Network
state: Florida
city: Tamarac
country: United States
facility: South Florida Wound Care Group
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Jacksonville
country: United States
facility: Passavant Area Hospital
state: Illinois
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Toms River
country: United States
facility: Oceana Country Foot and Ankle
state: New Jersey
city: New York
country: United States
facility: St Luke's - Roosevelt Hospital Center Department of Surgery
state: New York
city: New York
country: United States
facility: Stonybrook Univeristy Medical Center
state: New York
city: Tulsa
country: United States
facility: St. John Wound Center
state: Oklahoma
city: Erie
country: United States
facility: Penn North Center For Advanced Wound Care
state: Pennsylvania
city: Kittaning
country: United States
facility: Penn North Center For Advanced Wound Care
state: Pennsylvania
city: Wyomissing
country: United States
facility: Center For Advanced Wound Care
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: Saint Paul's Women's Center
state: Texas
city: St. Geroge
country: United States
facility: DRMC Wound Clinic
state: Utah
city: Sydney
country: Australia
facility: South Sydney Vascular Centre
state: New South Wales
city: Melbourne
country: Australia
facility: Heidelberg Repatriation Hospital
state: Victoria
city: Manukau
country: New Zealand
facility: Awhinatina Health
state: Auckland
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
state: Otago
city: Johannesburg
country: South Africa
facility: Dr D. Lakha
state: Gauteng
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Cape Town
country: South Africa
facility: Boland Ethical Research Group
city: Durban
country: South Africa
facility: Randles Road Medical Centre
city: Johannesburg
country: South Africa
facility: Unitas Hospital
city: Johannesburg
country: South Africa
facility: WorthwhileClinical Trials
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
city: Johannesburg
country: South Africa
facility: Witwatersrand University Medical School
city: Port Elizabeth
country: South Africa
facility: GCT Mercantile Clinical Trial Centre
Study officials:
affiliation: Penn North Centers For Advanced Wound Care, PA, USA
name: Tom Serena, MD
role: PRINCIPAL_INVESTIGATOR
References: