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 treatment of non-infected skin leg ulcers, due to venous insufficiency. - TOPICAL II

Phase 1

• Conditions: Venous Insufficiency Leg Ulcers

• Registration Number: EUCTR2004-002122-22-GB
• Lead Sponsor: Intercytex Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-27
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 412

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 insuffciency. Doppler will be utilized to rule out arterial disease.
4. Individuals who have a target wound which is between 2 cm squared to 20 cm squared in area at the screening assessment.
5. Individuals who are ambulatory.
6. Individuals who have voluntarily signed and dated a patient Informed Consent Form (ICF).
7. Individuals, who are, in the opinion of the investigator, able to understand this study, co-operate with teh study procedures and are willing to return to the clinci for all the required follow-up visits.
8. Sub-study only: Patients who are Female
9. Sub-study only: Have a coagulation profile which, in the opinion of the Investigator, would not result in excessive bleeding during biopsy procedure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Indiviudals with a known hypersensitivity to Aprotinin or any other constitutents of Tisseel VH S/D, 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 practising 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 rheumatiod 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 the Investigator suspects may be severly infected.
10. Individuals who have any clinically significant medical condition that would impair wound healing as determined by the investogator, 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 corticosteriods 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.
18. Sub-study only: Individuals who have a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
19. Individuals who have an abnormal PT, PTT or platelet value defined as 1.5 times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant.
20. Sub-study only: Individuals who are taking more than 2 tablets of 81 mg Aspirin per day or any dose of Coumadin on a regular basis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified