Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg Ulcers
- Conditions
- Leg Ulcer
- Registration Number
- NCT00232973
- Lead Sponsor
- Intercytex
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 396
- Individuals who have a graft-ready venous leg ulcer of at least 3 months duration, which has not, responded to standard conventional therapy.
- Individuals who have an Ankle Brachial Pressure Index (ABPI/ABI) of greater than or equal to 0.8 measured by Doppler sonography.
- 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.
- Individuals who have a target wound which is between 2 cm2 to 20 cm2 in area at the screening assessment.
- Individuals who are ambulatory.
- Individuals who have voluntarily signed and dated a patient IRB/EC approved Informed Consent Form (ICF).
- 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.
- 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.
- 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.
- 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.
- Individuals younger than 18 years of age.
- 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.
- Individuals who have exposed bone, tendon or fascia visible around the target wound.
- Individuals with evidence of collagen vascular diseases, such as vasculitis or rheumatoid arthritis, under active treatment.
- Individuals with evidence of cellulitis or osteomyelitis during the previous 4 weeks.
- 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.
- 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.
- Individuals who are known to abuse alcohol or drugs currently, or to have psychological disorders that could affect follow-up care or treatment outcomes.
- Individuals who have chronic renal insufficiency requiring haemodialysis.
- Individuals who have received short course corticosteroids within 30 days, or oral or parenteral chronic immunosupressants within 90 days prior to treatment.
- 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.
- Individuals who have participated in a clinical study of any investigational product within 2 months prior to treatment.
- Individuals who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Individuals previously enrolled/randomized in this clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period. 12 weeks
- Secondary Outcome Measures
Name Time Method Time to first closure. Overall rate of wound area reduction during treatment. 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. Appearance of new ulcer in the target wound area post closure.
Trial Locations
- Locations (56)
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
Central Washington Podiatry
🇺🇸Yakima, Washington, United States
University of Florida, Department of Surgery
🇺🇸Gainesville, Florida, United States
Bay Area Foot Care
🇺🇸Castro Valley, California, United States
Institute for Advanced Wound Care
🇺🇸Montgomery, Alabama, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Prairie Vascular Institute
🇺🇸Springfield, Illinois, United States
Dr. Robert Snyder
🇺🇸Tamarac, Florida, United States
Russells Hall Hospital
🇬🇧Dudley, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Wrexham Maelor Hospital
🇬🇧Wrexham, United Kingdom
Vascular Surgical Unit, Leeds General Infirmary
🇬🇧Leeds, United Kingdom
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Manzainto Medical Clinic
🇺🇸Carmichael, California, United States
M Limova, MD
🇺🇸Fresno, California, United States
Bay Area Foot care
🇺🇸San Francisco, California, United States
Dr Francisco Kerdel
🇺🇸Miami, Florida, United States
Advanced Foot and Ankle Center
🇺🇸Las Vegas, Nevada, United States
OSU Comprehensive Wound Center
🇺🇸Columbus, Ohio, United States
Gary Sibbald, MD
🇨🇦Mississauga, Ontario, Canada
Armstrong County Memorial Hospital
🇺🇸Kittanning, Pennsylvania, United States
Dermatology Daycare
🇨🇦Toronto, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science
🇺🇸North Chicago, Illinois, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Alameda County Medical Center
🇺🇸Alameda, California, United States
VA Medical Center
🇺🇸Sacramento, California, United States
The Wound Healing Center
🇺🇸Terre Haute, Indiana, United States
Dermatology, PLLC
🇺🇸Ann Arbor, Michigan, United States
Boston Medical Center, Department of Vascular Surgery
🇺🇸Boston, Massachusetts, United States
Dermatology and Cosmetic Specialists
🇺🇸Miramar, Florida, United States
National Centre for Limb Preservation
🇺🇸Niles, Illinois, United States
Doctor's Research Network
🇺🇸Miami, Florida, United States
St Vincent Health Center
🇺🇸Erie, Pennsylvania, United States
Parkwood Hospital, St Joseph's Health Care
🇨🇦London, Ontario, Canada
UNC Wound Care Clinic
🇺🇸Chapel Hill, North Carolina, United States
Roger Williams Medical Centre
🇺🇸Providence, Rhode Island, United States
Penn North Centers for Advanced Wound Care
🇺🇸Warren, Pennsylvania, United States
Entralogix
🇨🇦Welland, Ontario, Canada
Centre Medical Ste-Dorothee
🇨🇦Laval, Quebec, Canada
Department of Vascular Surgery, Manchester Royal Infirmary
🇬🇧Manchester, Lancashire, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Clatterbridge Hospital, Surgical Outpatients
🇬🇧Upton, Wirral, United Kingdom
Birmingham Heartlands Hospital, University Department of Vascular Surgery
🇬🇧Birmingham, United Kingdom
St Richards Hospital
🇬🇧Chichester, United Kingdom
Cardiff University
🇬🇧Cardiff, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
The Willows Centre for Health
🇬🇧Salford, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Arrowe Park Hospital
🇬🇧Upton, United Kingdom
Montefiore Medical Center
🇺🇸Bronx, New York, United States