Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg Ulcers
NCT ID: NCT00232973
Last Updated: 2008-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
396 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ICXP007
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Intercytex
INDUSTRY
Responsible Party
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Intercytex
Locations
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Institute for Advanced Wound Care
Montgomery, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Alameda County Medical Center
Alameda, California, United States
Manzainto Medical Clinic
Carmichael, California, United States
Bay Area Foot Care
Castro Valley, California, United States
M Limova, MD
Fresno, California, United States
VA Medical Center
Sacramento, California, United States
Bay Area Foot care
San Francisco, California, United States
University of Florida, Department of Surgery
Gainesville, Florida, United States
Dr Francisco Kerdel
Miami, Florida, United States
Doctor's Research Network
Miami, Florida, United States
Dermatology and Cosmetic Specialists
Miramar, Florida, United States
Dr. Robert Snyder
Tamarac, Florida, United States
National Centre for Limb Preservation
Niles, Illinois, United States
Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science
North Chicago, Illinois, United States
Prairie Vascular Institute
Springfield, Illinois, United States
The Wound Healing Center
Terre Haute, Indiana, United States
Boston Medical Center, Department of Vascular Surgery
Boston, Massachusetts, United States
Dermatology, PLLC
Ann Arbor, Michigan, United States
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC Wound Care Clinic
Chapel Hill, North Carolina, United States
OSU Comprehensive Wound Center
Columbus, Ohio, United States
OSU Comprehensive Wound Center
Columbus, Ohio, United States
St Vincent Health Center
Erie, Pennsylvania, United States
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States
Penn North Centers for Advanced Wound Care
Warren, Pennsylvania, United States
Roger Williams Medical Centre
Providence, Rhode Island, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Central Washington Podiatry
Yakima, Washington, United States
Western Canada Dermatology Institute
Edmonton, Alberta, Canada
Clinical Trials Unit, Skin Care Centre
Vancouver, British Columbia, Canada
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, Canada
Parkwood Hospital, St Joseph's Health Care
London, Ontario, Canada
Gary Sibbald, MD
Mississauga, Ontario, Canada
Entralogix
Oakville, Ontario, Canada
Dermatology Daycare
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Entralogix
Welland, Ontario, Canada
Centre Medical Ste-Dorothee
Laval, Quebec, Canada
Department of Vascular Surgery, Manchester Royal Infirmary
Manchester, Lancashire, United Kingdom
Clatterbridge Hospital, Surgical Outpatients
Upton, Wirral, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Birmingham Heartlands Hospital, University Department of Vascular Surgery
Birmingham, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Cardiff University
Cardiff, , United Kingdom
St Richards Hospital
Chichester, , United Kingdom
Russells Hall Hospital
Dudley, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Vascular Surgical Unit, Leeds General Infirmary
Leeds, , United Kingdom
St George's Hospital
London, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
The Willows Centre for Health
Salford, , United Kingdom
Arrowe Park Hospital
Upton, , United Kingdom
Wrexham Maelor Hospital
Wrexham, , United Kingdom
Countries
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Facility Contacts
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Heather Kimbriel
Role: primary
Maureen Lifton
Role: backup
Other Identifiers
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02-VLU-003
Identifier Type: -
Identifier Source: org_study_id
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