The main purpose of the study is to compare treatment of non-infected venous leg ulcers using
ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer
compression bandaging and four-layer compression bandaging alone.
Time to first closure.
Incidence of closure at 16, 20 and 24 weeks.
Incidence of reopening at up to 16, 20 and 24 weeks.
Incidence of re-closure at 16, 20 and 24 weeks.
Qualitative levels of wound pain.
Percentage of Day 0 wound surface area.
Percentage reduction in wound surface area from previous visit.
Percentage reduction in wound surface area from Day 0.
Inclusion Criteria:
1. Individuals who have a graft-ready venous leg ulcer of at least 3 months duration,
which has not, responded to standard conventional therapy.
2. Individuals who have an Ankle Brachial Pressure Index (ABPI/ABI) of greater than or
equal to 0. 8 measured by Doppler sonography.
3. Individuals who have venous incompetency as defined by > 1. 0 seconds in vein segments
on standing reflux exam by duplex or an abnormal venous refill time of < 21 seconds by
PPG or > 2 cc per second by APG. Duplex or PPG/APG will be used to establish venous
insufficiency. Doppler will be utilized to rule out arterial disease.
4. Individuals who have a target wound which is between 2 cm2 to 20 cm2 in area at the
screening assessment.
5. Individuals who are ambulatory.
6. Individuals who have voluntarily signed and dated a patient IRB/EC approved Informed
Consent Form (ICF).
7. Individuals, who are, in the opinion of the Investigator, able to understand this
study, co-operate with the study procedures and are willing to return to the clinic
for all the required follow-up visits.
Exclusion Criteria:
1. Individuals with a known hypersensitivity to Aprotinin or any other constituents of
Tisseel VH S/DTM i. e. Fibrinogen (human), thrombin (human) and Calcium Chloride,
Bovine and Porcine products.
2. Individuals who have a haemoglobin or serum albumin level which is < 10 g/dL or < 2. 5
g/dL respectively, or is otherwise outside the normal range and deemed clinically
significant.
3. Females who are pregnant, lactating, or who have not reached menopause and are not
abstinent or practicing an acceptable means of birth control as determined by the
Investigator for the duration of the study.
4. Individuals younger than 18 years of age.
5. Individuals with abnormal blood biochemistry defined as 3 times that of the upper
limit of the normal range and/or any other abnormal laboratory finding considered
clinically significant.
6. Individuals who have exposed bone, tendon or fascia visible around the target wound.
7. Individuals with evidence of collagen vascular diseases, such as vasculitis or
rheumatoid arthritis, under active treatment.
8. Individuals with evidence of cellulitis or osteomyelitis during the previous 4 weeks.
9. Individuals who have a target wound which shows signs of clinical infection or who
have a wound that has presence of ß-haemolytic streptococcus upon culture, or the
Investigator suspects may be severely infected. Individuals may be enrolled upon
eradication of the ß-haemolytic streptococcus infection/organism.
10. Individuals who have any clinically significant medical condition that would impair
wound healing as determined by the Investigator, including uncontrolled diabetes as
determined by HbA1C (>12%), or immune disease.
11. Individuals who are known to abuse alcohol or drugs currently, or to have
psychological disorders that could affect follow-up care or treatment outcomes.
12. Individuals who have chronic renal insufficiency requiring haemodialysis.
13. Individuals who have received short course corticosteroids within 30 days, or oral or
parenteral chronic immunosupressants within 90 days prior to treatment.
14. Individuals 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. Individuals who have participated in a clinical study of any investigational product
within 2 months prior to treatment.
16. Individuals who, in the opinion of the Investigator, have an existing condition that
would compromise their participation and follow-up in this study.
17. Individuals previously enrolled/randomized in this clinical trial.
Arrowe Park Hospital, Upton CH49 5PE, United Kingdom; Recruiting
Gwen Lawrence, Phone: 0151 678 5111, Ext: 8362, Email: gwen.lawrence@whnt.nhs.uk
Stephen Blair, MS, FRCS, Principal Investigator
Birmingham Heartlands Hospital, University Department of Vascular Surgery, Birmingham B9 5SS, United Kingdom; Recruiting
Emma Burke, Email: emma.burke@heartofengland.nhs.uk
Andrew Bradbury, BSc, MBChB, MD, FRCS Ed, Principal Investigator
Vascular Surgical Unit, Leeds General Infirmary, Leeds LS1 3EX, United Kingdom; Terminated
Russells Hall Hospital, Dudley DY1 2HQ, United Kingdom; Recruiting
Joy Lewis, Phone: 01384 456111, Email: joy.lewis@dgoh.nhs.uk
Sandy Shiralkar, MBBS, MS, FRCS, EBSQ, Principal Investigator
Bradford Royal Infirmary, Bradford BD9 6RJ, United Kingdom; Active, not recruiting
Cardiff University, Cardiff CF14 4XN, United Kingdom; Recruiting
Nicola Ivins, Phone: 029 20 746319, Email: ivinsnm@Cardiff.ac.uk
Keith Harding, Principal Investigator
Hull Royal Infirmary, Hull HU3 2JZ, United Kingdom; Recruiting
Josie Hatfield, Phone: +44 (0) 1482 674389, Email: josie.hatfield@hey.nhs.uk
Ian Chetter, Principal Investigator
Wrexham Maelor Hospital, Wrexham LL13 7TD, United Kingdom; Recruiting
Ruby Griffiths, Phone: 01978 725 124, Email: ruby.griffiths@new-tr.wales.nhs.uk
Tony Da Silva, Principal Investigator
Derriford Hospital, Plymouth PL6 8HD, United Kingdom; Recruiting
Chryz Cosgrove, Phone: 01752 439226, Email: chryz.cosgrove@phnt.swest.nhs.uk
Alan Elstone, Email: alan.elstone@phnt.swest.nhs.uk
Alasdair Walker, Principal Investigator
The Willows Centre for Health, Salford M5 5JR, United Kingdom; Not yet recruiting
Silvia Stanway, Phone: 0161 212 4378, Email: sylvia.stanway@salford-pct.nhs.uk
John V Smyth, Principal Investigator
St George's Hospital, London SW17 0QT, United Kingdom; Not yet recruiting
Gill Horne, Phone: 0208 725 2877, Email: gillian.horne@stgeorges.nhs.uk
Ian Loftus, Principal Investigator
Belfast City Hospital, Belfast BT9 1NR, United Kingdom; Not yet recruiting
Gillian Swain, Phone: 02890 329 241, Ext: 2038, Email: gillian.swain@belfasttrust.hscni.net
Louis Lau, Principal Investigator
St Richards Hospital, Chichester PO19 6SE, United Kingdom; Not yet recruiting
Hilary Ashton, Phone: 01243 831503, Email: hilary.ashton@rws-tr.nhs.uk
Hany Hafez, Principal Investigator
Aberdeen Royal Infirmary, Aberdeen AB25 2ZN, United Kingdom; Recruiting
Rhoda MacKenzie, Phone: 01224 552281, Email: rhodamackenzie@nhs.net
Paul Bachoo, Principal Investigator
Gloucestershire Royal Hospital, Gloucester GL1 3NN, United Kingdom; Recruiting
Julie Stephens, Phone: 0845 422 6190, Email: julie.stephens@glos.nhs.uk
Jonathan Earnshaw, Principal Investigator
Institute for Advanced Wound Care, Montgomery, Alabama 36111, United States; Terminated
Western Canada Dermatology Institute, Edmonton, Alberta T5J 3S9, Canada; Terminated
Southern Arizona VA Health Care System, Tucson, Arizona 85723, United States; Recruiting
Heather Kimbriel, Phone: 520-792-1450, Ext: 6625
Maureen Lifton, Phone: 520 792 1450, Ext: 6625
Jodi Walters, MD, Principal Investigator
HOPE Research Institute, Phoenix, Arizona 85050, United States; Recruiting
Jason Haile, Phone: 602-288-4673, Email: jason.haile@hriaz.com
Arthur Tallis, MD, Principal Investigator
Clinical Trials Unit, Skin Care Centre, Vancouver, British Columbia V5Z 4E8, Canada; Completed
M Limova, MD, Fresno, California 93711, United States; Active, not recruiting
Bay Area Foot Care, Castro Valley, California 94546, United States; Active, not recruiting
Bay Area Foot care, San Francisco, California 94115, United States; Active, not recruiting
VA Medical Center, Sacramento, California 95655, United States; Active, not recruiting
Manzainto Medical Clinic, Carmichael, California 95608, United States; Recruiting
Nadia Radchenko, Phone: 916-979-0621, Email: nadyusharad@yahoo.com
James Greenberg, MD, Principal Investigator
Pavel Polskiy, MD, Sub-Investigator
Alameda County Medical Center, Alameda, California 94602, United States; Withdrawn
Dermatology and Cosmetic Specialists, Miramar, Florida 33027, United States; Terminated
Dr Francisco Kerdel, Miami, Florida 33136, United States; Active, not recruiting
University of Florida, Department of Surgery, Gainesville, Florida 32610, United States; Terminated
Doctor's Research Network, Miami, Florida 33143, United States; Recruiting
Yvette Salamanca, Phone: 305-662-1444, Email: jrhsbri@aol.com
Jason Hanft, Principal Investigator
Dr. Robert Snyder, Tamarac, Florida 33321, United States; Recruiting
Suzanne Wujceak, Phone: 954-721-4806, Email: drwound@aol.com
Robert Snyder, MD, Principal Investigator
Prairie Vascular Institute, Springfield, Illinois 62702, United States; Recruiting
Mark Sanders, Phone: 217-544-6464, Ext: 66072, Email: msanders@prairierheart.com
Raghu Kolluri, Principal Investigator
Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science, North Chicago, Illinois 60064, United States; Recruiting
Catherine Griffis, Phone: 210-464-4053, Email: catherine.griffis@rosalindfranklin.edu
David Armstrong, MD, Principal Investigator
National Centre for Limb Preservation, Niles, Illinois 60714, United States; Recruiting
Julie Anderson, Phone: 847-723-3004, Email: julie.anderson@advocatehealth.com
Stephanie Wu, MD, Principal Investigator
The Wound Healing Center, Terre Haute, Indiana 47807, United States; Terminated
Department of Vascular Surgery, Manchester Royal Infirmary, Manchester, Lancashire M13 9WL, United Kingdom; Active, not recruiting
Boston Medical Center, Department of Vascular Surgery, Boston, Massachusetts 02118, United States; Recruiting
Marina Malikova, Phone: 617-414-6836, Email: marina@biochem.bumc.bu.edu
Alik Faber, MD, Principal Investigator
Dermatology, PLLC, Ann Arbor, Michigan 48103, United States; Active, not recruiting
Advanced Foot and Ankle Center, Las Vegas, Nevada 89119, United States; Recruiting
Joseph Dove, Phone: 702-696-9005, Email: cyaandidove@msn.com
Cyaandi Dove, MD, Principal Investigator
Montefiore Medical Center, Bronx, New York 10467-2490, United States; Not yet recruiting
Katey Fahey, Phone: 718-920-5961, Email: kfahey@montefiore.org
Evan Lipsitz, MD, Principal Investigator
UNC Wound Care Clinic, Chapel Hill, North Carolina 27599, United States; Recruiting
Nicolle Lemire, Phone: 919-484-1437, Ext: 278, Email: nlemire@med.unc.edu
William Marston, MD, Principal Investigator
Eastern Canada Cutaneous Research Associates Ltd, Halifax, Nova Scotia B3H 1Z4, Canada; Terminated
OSU Comprehensive Wound Center, Columbus, Ohio 43221, United States; Recruiting
Kathy Owen, Phone: 614-257-2414, Email: kathy.owen@osumc.edu
Lynn Lambert, Phone: 614 886 3690, Email: lynn.lambert@osumc.edu
Gayle Gordillo, MD, Principal Investigator
OSU Comprehensive Wound Center, Columbus, Ohio 43205, United States; Recruiting
Kathy Owen, Phone: 614-257-2414, Email: kathy.owen@osumc.edu
Lynn Lambert, Phone: 614 886 3690, Email: lynn.lambert@osumc.edu
Gayle Gordillo, MD, Principal Investigator
Parkwood Hospital, St Joseph's Health Care, London, Ontario N6C 2J1, Canada; Recruiting
Anne Lemesurier, RN, Phone: 519 685 4292, Ext: 42163, Email: anne.lemesurier@sjhc.london.on.ca
David Keast, MD, Principal Investigator
Gary Sibbald, MD, Mississauga, Ontario L4Y 1A6, Canada; Completed
Dermatology Daycare, Toronto, Ontario M5S 1B2, Canada; Completed
Entralogix, Oakville, Ontario L6K 1E1, Canada; Recruiting
Vito Losito, Phone: 905-898-0716, Ext: 206, Email: vitolosito@entralogix.com
Kristin Ingraham, Phone: 905 898 0716, Email: kristiningraham@entralogix.com
Sylvia Garnis-Jones, Principal Investigator
Entralogix, Welland, Ontario L0S 1C0, Canada; Recruiting
Vito Losito, Phone: 905-898-0716, Ext: 206, Email: vitolosito@entralogix.com
Kristin Ingraham, Phone: 905 898 0716, Email: kristiningraham@entralogix.com
Sylvia Garnis-Jones, Principal Investigator
St Michael's Hospital, Toronto, Ontario M5W 1WB, Canada; Recruiting
Tobi Mark, Phone: 416 864-6060, Ext: 2162, Email: markt@smh.toronto.on.ca
James Mahoney, Principal Investigator
Penn North Centers for Advanced Wound Care, Warren, Pennsylvania 16365, United States; Recruiting
Cris Beuger, Phone: 814-688-5008, Email: cbeuger@healingwounds.com
Thomas Serena, Principal Investigator
Armstrong County Memorial Hospital, Kittanning, Pennsylvania 16201, United States; Recruiting
Lisa Brumbaugh, Phone: 724-543-8536, Email: brumbaughl@acmh.org
Thomas Serena, MD, Principal Investigator
St Vincent Health Center, Erie, Pennsylvania 16544, United States; Recruiting
Cris Beuger, Phone: 814-452-7878, Email: cbeuger@healingwounds.com
Thomas Serena, MD, Principal Investigator
Centre Medical Ste-Dorothee, Laval, Quebec H7X 3S5, Canada; Completed
Roger Williams Medical Centre, Providence, Rhode Island 02908, United States; Recruiting
Jaymie Panuncialman, Phone: 401-456-2203, Email: jpanuncialman@rwmc.org
Vincent Falanga, MD, Principal Investigator
Central Washington Podiatry, Yakima, Washington 98902, United States; Active, not recruiting
Madigan Army Medical Center, Tacoma, Washington 98431, United States; Recruiting
Billi Tatum, Phone: 253-968-2429, Email: billi.tatum@us.arm.mil
Charles Anderson, Principal Investigator
Clatterbridge Hospital, Surgical Outpatients, Upton, Wirral CH49 5PE, United Kingdom; Recruiting
Gwen Lawrence, Email: gwen.lawrence@whnt.nhs.uk
Stephen Blair, MS, FRCS, Principal Investigator
