Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232973
Recruitment Status : Unknown
Verified February 2008 by Intercytex.
Recruitment status was:  Recruiting
First Posted : October 5, 2005
Last Update Posted : February 5, 2008
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leg Ulcer Drug: ICXP007 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Centre, Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Safety and Efficacy of ICXP007 in a Phase III Trial With Four-Layer Therapeutic Compression, for the Treatment of Non-Infected Skin Leg Ulcers, Due to Venous-Insufficiency
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Overall rate of wound area reduction during treatment.
  2. Time to first closure.
  3. Incidence of closure at 16, 20 and 24 weeks.
  4. Incidence of reopening at up to 16, 20 and 24 weeks.
  5. Incidence of re-closure at 16, 20 and 24 weeks.
  6. Qualitative levels of wound pain.
  7. Percentage of Day 0 wound surface area.
  8. Percentage reduction in wound surface area from previous visit.
  9. Percentage reduction in wound surface area from Day 0.
  10. Appearance of new ulcer in the target wound area post closure.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232973

  Hide Study Locations
United States, Alabama
Institute for Advanced Wound Care Terminated
Montgomery, Alabama, United States, 36111
United States, Arizona
HOPE Research Institute Recruiting
Phoenix, Arizona, United States, 85050
Contact: Jason Haile    602-288-4673   
Principal Investigator: Arthur Tallis, MD         
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Heather Kimbriel    520-792-1450 ext 6625      
Contact: Maureen Lifton    520 792 1450 ext 6625      
Principal Investigator: Jodi Walters, MD         
United States, California
Alameda County Medical Center Withdrawn
Alameda, California, United States, 94602
Manzainto Medical Clinic Recruiting
Carmichael, California, United States, 95608
Contact: Nadia Radchenko    916-979-0621   
Principal Investigator: James Greenberg, MD         
Sub-Investigator: Pavel Polskiy, MD         
Bay Area Foot Care Active, not recruiting
Castro Valley, California, United States, 94546
M Limova, MD Active, not recruiting
Fresno, California, United States, 93711
VA Medical Center Active, not recruiting
Sacramento, California, United States, 95655
Bay Area Foot care Active, not recruiting
San Francisco, California, United States, 94115
United States, Florida
University of Florida, Department of Surgery Terminated
Gainesville, Florida, United States, 32610
Dr Francisco Kerdel Active, not recruiting
Miami, Florida, United States, 33136
Doctor's Research Network Recruiting
Miami, Florida, United States, 33143
Contact: Yvette Salamanca    305-662-1444   
Principal Investigator: Jason Hanft         
Dermatology and Cosmetic Specialists Terminated
Miramar, Florida, United States, 33027
Dr. Robert Snyder Recruiting
Tamarac, Florida, United States, 33321
Contact: Suzanne Wujceak    954-721-4806   
Principal Investigator: Robert Snyder, MD         
United States, Illinois
National Centre for Limb Preservation Recruiting
Niles, Illinois, United States, 60714
Contact: Julie Anderson    847-723-3004   
Principal Investigator: Stephanie Wu, MD         
Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science Recruiting
North Chicago, Illinois, United States, 60064
Contact: Catherine Griffis    210-464-4053   
Principal Investigator: David Armstrong, MD         
Prairie Vascular Institute Recruiting
Springfield, Illinois, United States, 62702
Contact: Mark Sanders    217-544-6464 ext 66072   
Principal Investigator: Raghu Kolluri         
United States, Indiana
The Wound Healing Center Terminated
Terre Haute, Indiana, United States, 47807
United States, Massachusetts
Boston Medical Center, Department of Vascular Surgery Recruiting
Boston, Massachusetts, United States, 02118
Contact: Marina Malikova    617-414-6836   
Principal Investigator: Alik Faber, MD         
United States, Michigan
Dermatology, PLLC Active, not recruiting
Ann Arbor, Michigan, United States, 48103
United States, Nevada
Advanced Foot and Ankle Center Recruiting
Las Vegas, Nevada, United States, 89119
Contact: Joseph Dove    702-696-9005   
Principal Investigator: Cyaandi Dove, MD         
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467-2490
Contact: Katey Fahey    718-920-5961   
Principal Investigator: Evan Lipsitz, MD         
United States, North Carolina
UNC Wound Care Clinic Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Nicolle Lemire    919-484-1437 ext 278   
Principal Investigator: William Marston, MD         
United States, Ohio
OSU Comprehensive Wound Center Recruiting
Columbus, Ohio, United States, 43205
Contact: Kathy Owen    614-257-2414   
Contact: Lynn Lambert    614 886 3690   
Principal Investigator: Gayle Gordillo, MD         
OSU Comprehensive Wound Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Kathy Owen    614-257-2414   
Contact: Lynn Lambert    614 886 3690   
Principal Investigator: Gayle Gordillo, MD         
United States, Pennsylvania
St Vincent Health Center Recruiting
Erie, Pennsylvania, United States, 16544
Contact: Cris Beuger    814-452-7878   
Principal Investigator: Thomas Serena, MD         
Armstrong County Memorial Hospital Recruiting
Kittanning, Pennsylvania, United States, 16201
Contact: Lisa Brumbaugh    724-543-8536   
Principal Investigator: Thomas Serena, MD         
Penn North Centers for Advanced Wound Care Recruiting
Warren, Pennsylvania, United States, 16365
Contact: Cris Beuger    814-688-5008   
Principal Investigator: Thomas Serena         
United States, Rhode Island
Roger Williams Medical Centre Recruiting
Providence, Rhode Island, United States, 02908
Contact: Jaymie Panuncialman    401-456-2203   
Principal Investigator: Vincent Falanga, MD         
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Billi Tatum    253-968-2429   
Principal Investigator: Charles Anderson         
Central Washington Podiatry Active, not recruiting
Yakima, Washington, United States, 98902
Canada, Alberta
Western Canada Dermatology Institute Terminated
Edmonton, Alberta, Canada, T5J 3S9
Canada, British Columbia
Clinical Trials Unit, Skin Care Centre Completed
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd Terminated
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Parkwood Hospital, St Joseph's Health Care Recruiting
London, Ontario, Canada, N6C 2J1
Contact: Anne Lemesurier, RN    519 685 4292 ext 42163   
Principal Investigator: David Keast, MD         
Gary Sibbald, MD Completed
Mississauga, Ontario, Canada, L4Y 1A6
Entralogix Recruiting
Oakville, Ontario, Canada, L6K 1E1
Contact: Vito Losito    905-898-0716 ext 206   
Contact: Kristin Ingraham    905 898 0716   
Principal Investigator: Sylvia Garnis-Jones         
Dermatology Daycare Completed
Toronto, Ontario, Canada, M5S 1B2
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5W 1WB
Contact: Tobi Mark    416 864-6060 ext 2162   
Principal Investigator: James Mahoney         
Entralogix Recruiting
Welland, Ontario, Canada, L0S 1C0
Contact: Vito Losito    905-898-0716 ext 206   
Contact: Kristin Ingraham    905 898 0716   
Principal Investigator: Sylvia Garnis-Jones         
Canada, Quebec
Centre Medical Ste-Dorothee Completed
Laval, Quebec, Canada, H7X 3S5
United Kingdom
Department of Vascular Surgery, Manchester Royal Infirmary Active, not recruiting
Manchester, Lancashire, United Kingdom, M13 9WL
Clatterbridge Hospital, Surgical Outpatients Recruiting
Upton, Wirral, United Kingdom, CH49 5PE
Contact: Gwen Lawrence   
Principal Investigator: Stephen Blair, MS, FRCS         
Aberdeen Royal Infirmary Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Contact: Rhoda MacKenzie    01224 552281   
Principal Investigator: Paul Bachoo         
Belfast City Hospital Not yet recruiting
Belfast, United Kingdom, BT9 1NR
Contact: Gillian Swain    02890 329 241 ext 2038   
Principal Investigator: Louis Lau         
Birmingham Heartlands Hospital, University Department of Vascular Surgery Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Emma Burke   
Principal Investigator: Andrew Bradbury, BSc, MBChB, MD, FRCS Ed         
Bradford Royal Infirmary Active, not recruiting
Bradford, United Kingdom, BD9 6RJ
Cardiff University Recruiting
Cardiff, United Kingdom, CF14 4XN
Contact: Nicola Ivins    029 20 746319   
Principal Investigator: Keith Harding         
St Richards Hospital Not yet recruiting
Chichester, United Kingdom, PO19 6SE
Contact: Hilary Ashton    01243 831503   
Principal Investigator: Hany Hafez         
Russells Hall Hospital Recruiting
Dudley, United Kingdom, DY1 2HQ
Contact: Joy Lewis    01384 456111   
Principal Investigator: Sandy Shiralkar, MBBS, MS, FRCS, EBSQ         
Gloucestershire Royal Hospital Recruiting
Gloucester, United Kingdom, GL1 3NN
Contact: Julie Stephens    0845 422 6190   
Principal Investigator: Jonathan Earnshaw         
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Josie Hatfield    +44 (0) 1482 674389   
Principal Investigator: Ian Chetter         
Vascular Surgical Unit, Leeds General Infirmary Terminated
Leeds, United Kingdom, LS1 3EX
St George's Hospital Not yet recruiting
London, United Kingdom, SW17 0QT
Contact: Gill Horne    0208 725 2877   
Principal Investigator: Ian Loftus         
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8HD
Contact: Chryz Cosgrove    01752 439226   
Contact: Alan Elstone   
Principal Investigator: Alasdair Walker         
The Willows Centre for Health Not yet recruiting
Salford, United Kingdom, M5 5JR
Contact: Silvia Stanway    0161 212 4378   
Principal Investigator: John V Smyth         
Arrowe Park Hospital Recruiting
Upton, United Kingdom, CH49 5PE
Contact: Gwen Lawrence    0151 678 5111 ext 8362   
Principal Investigator: Stephen Blair, MS, FRCS         
Wrexham Maelor Hospital Recruiting
Wrexham, United Kingdom, LL13 7TD
Contact: Ruby Griffiths    01978 725 124   
Principal Investigator: Tony Da Silva         
Sponsors and Collaborators

Responsible Party: Intercytex Identifier: NCT00232973     History of Changes
Other Study ID Numbers: 02-VLU-003
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: February 5, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases