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

ClinicalTrials.gov ID

NCT00232973

Lead Sponsor

IntercytexINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

396Estimated

Last Update Posted

Feb 5, 2008Estimated

Start Date

Jul 2005

Official Title

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

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.

• Leg Ulcer

• ICXP007

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

IntercytexINDUSTRY

jrhsbri@aol.com305-662-1444

drwound@aol.com954-721-4806

vitolosito@entralogix.com905-898-0716 ext. 206

markt@smh.toronto.on.ca416 864-6060 ext. 2162

vitolosito@entralogix.com905-898-0716 ext. 206

rhodamackenzie@nhs.net01224 552281

gillian.swain@belfasttrust.hscni.net02890 329 241 ext. 2038

ivinsnm@Cardiff.ac.uk029 20 746319

joy.lewis@dgoh.nhs.uk01384 456111

josie.hatfield@hey.nhs.uk+44 (0) 1482 674389

gillian.horne@stgeorges.nhs.uk0208 725 2877

chryz.cosgrove@phnt.swest.nhs.uk01752 439226

gwen.lawrence@whnt.nhs.uk0151 678 5111 ext. 8362

ruby.griffiths@new-tr.wales.nhs.uk01978 725 124

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