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



Status:Recruiting
Conditions:Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:July 2005

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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

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.


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.
We found this trial at
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Warren, Pennsylvania 16365
2164
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Warren, PA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1600 Southwest Archer Road
Gainesville, Florida 32610
2104
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3850 Hollywood Boulevard #301
Miramar, Florida 33027
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Tamarac, Florida 33321
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Alameda, California 94602
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Ann Arbor, Michigan 48103
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Boston, MA
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Carmichael, California 95608
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Castro Valley, California 94546
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Chapel Hill, North Carolina 27599
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Columbus, Ohio 43221
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Columbus, Ohio 43221
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Erie, Pennsylvania 16544
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Fresno, California 93711
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Kittanning, Pennsylvania 16201
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Las Vegas, Nevada 89119
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Miami, Florida 33136
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Miami, Florida 33143
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Montgomery, Alabama 36111
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Niles, IL
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Phoenix, Arizona 85050
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Providence, Rhode Island 02908
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Sacramento, California 95655
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San Francisco, California 94115
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Springfield, Illinois 62702
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9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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Terre Haute, Indiana 47807
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Yakima, Washington 98902
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