Last updated on February 2008

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Leg Ulcer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    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
    creening 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
    tudy, co-operate with the study procedures and are willing to return to the clinic
    for all the required follow-up visits.

You may not be eligible for this study if the following are true:

  • 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
    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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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