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

Intercytex56 sites in 3 countries396 target enrollmentJuly 2005

ConditionsLeg Ulcer

DrugsICXP007

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Leg Ulcer
Sponsor: Intercytex
Enrollment: 396
Locations: 56
Primary Endpoint: Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Intercytex

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.