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

Status unconfirmed · Phase 3

Conditions studied: Leg Ulcer

In brief

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.

Key facts

Study ID

NCT00232973

Run by

Intercytex

People needed

396

Starts

2005-07-01

Last updated by the study team

2008-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• Aberdeen Royal Infirmary — Aberdeen, United Kingdom (enrolling)
• Penn North Centers for Advanced Wound Care — Warren, Pennsylvania, United States (enrolling)
• Entralogix — Oakville, Ontario, Canada (enrolling)
• Entralogix — Welland, Ontario, Canada (enrolling)
• Clatterbridge Hospital, Surgical Outpatients — Upton, Wirral, United Kingdom (enrolling)
• HOPE Research Institute — Phoenix, Arizona, United States (enrolling)
• Armstrong County Memorial Hospital — Kittanning, Pennsylvania, United States (enrolling)
• Roger Williams Medical Centre — Providence, Rhode Island, United States (enrolling)
• Parkwood Hospital, St Joseph's Health Care — London, Ontario, Canada (enrolling)
• Doctor's Research Network — Miami, Florida, United States (enrolling)
• Southern Arizona VA Health Care System — Tucson, Arizona, United States (enrolling)
• Dr. Robert Snyder — Tamarac, Florida, United States (enrolling)
• National Centre for Limb Preservation — Niles, Illinois, United States (enrolling)
• Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science — North Chicago, Illinois, United States (enrolling)
• Prairie Vascular Institute — Springfield, Illinois, United States (enrolling)
• St Vincent Health Center — Erie, Pennsylvania, United States (enrolling)
• Boston Medical Center, Department of Vascular Surgery — Boston, Massachusetts, United States (enrolling)
• Manzainto Medical Clinic — Carmichael, California, United States (enrolling)
• Advanced Foot and Ankle Center — Las Vegas, Nevada, United States (enrolling)
• Madigan Army Medical Center — Tacoma, Washington, United States (enrolling)
• UNC Wound Care Clinic — Chapel Hill, North Carolina, United States (enrolling)
• OSU Comprehensive Wound Center — Columbus, Ohio, United States (enrolling)
• OSU Comprehensive Wound Center — Columbus, Ohio, United States (enrolling)
• Birmingham Heartlands Hospital, University Department of Vascular Surgery — Birmingham, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.